Heart valve sealing devices and delivery devices therefor

ABSTRACT

An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element formed from a strip of material; a pair of extension members; a pair of paddles formed from the strip of material and connected to the coaption element; and a cap attached to the paddles. The paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap has a retention body for receiving attachment portions of the extension members, a retaining nut, and a retaining bolt for securing the retaining nut.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/744,031, filed Oct. 10, 2018, the contents of which are incorporatedby reference in their entirety.

TECHNICAL FIELD

The present application relates generally to prosthetic devices andrelated methods for helping to seal native heart valves and prevent orreduce regurgitation therethrough, as well as devices and relatedmethods for implanting such prosthetic devices.

BACKGROUND OF THE INVENTION

The native heart valves (i.e., the aortic, pulmonary, tricuspid, andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be damaged, and thus rendered less effective, bycongenital malformations, inflammatory processes, infectious conditions,or disease. Such damage to the valves can result in seriouscardiovascular compromise or death. For many years the definitivetreatment for such damaged valves was surgical repair or replacement ofthe valve during open heart surgery. However, open heart surgeries arehighly invasive and are prone to many complications. Therefore, elderlyand frail patients with defective heart valves often went untreated.More recently, transvascular techniques have been developed forintroducing and implanting prosthetic devices in a manner that is muchless invasive than open heart surgery. One particular transvasculartechnique that is used for accessing the native mitral and aortic valvesis the trans-septal technique. The transseptal technique comprisesinserting a catheter into the right femoral vein, up the inferior venacava and into the right atrium. The septum is then punctured and thecatheter passed into the left atrium.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets, extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a “D”-shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally “C”-shapedboundary between the abutting sides of the leaflets when they are closedtogether.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or “diastole”), the oxygenated blood that iscollected in the left atrium flows into the left ventricle. When themuscles of the left atrium relax and the muscles of the left ventriclecontract (also referred to as “ventricular systole” or “systole”), theincreased blood pressure in the left ventricle urges the sides of thetwo leaflets together, thereby closing the one-way mitral valve so thatblood cannot flow back to the left atrium and is instead expelled out ofthe left ventricle through the aortic valve. To prevent the two leafletsfrom prolapsing under pressure and folding back through the mitralannulus toward the left atrium, a plurality of fibrous cords calledchordae tendineae tether the leaflets to papillary muscles in the leftventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systolic phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation and mitral regurgitation nearer to one commissure (i.e.,location where the leaflets meet) of the leaflets can be referred to aseccentric jet mitral regurgitation. Central jet regurgitation occurswhen the edges of the leaflets do not meet in the middle and thus thevalve does not close and regurgitation is present.

Some prior techniques for treating mitral regurgitation in patientsinclude surgically stitching the edges of the native mitral valveleaflets directly to one another. A catheter delivered clip has beenused to attempt to clip the sides of the leaflets together at the endportions of the leaflets, similar to the surgical stitching method.However, this clip has shortcomings, since it can only be used to clipthe middle of the leaflets where they overlap by about 2 mm or more.Alternately, attempts have been made to use multiple clips on thecommissures of the mitral valve, where there may be more overlap of theleaflets. This technique results in a longer operation time and alsojoins the patient's leaflets at the sides, restricting blood flow.Additionally, both the surgical and clip treatments are thought tocreate stress on patient leaflets.

Despite these prior techniques, there is a continuing need for improveddevices and methods for treating mitral valve regurgitation.

SUMMARY

Exemplary valve repair devices for repairing a native valve of a patientand methods of using the same are disclosed herein.

An exemplary valve repair device for repairing a native valve of apatient includes: a coaption element formed from a strip of material; apair of extension members; a pair of paddles formed from the strip ofmaterial and connected to the coaption element; and a cap attached tothe paddles. The paddles are movable between an open position and aclosed position, are disposed over the extension member, and areconfigured to attach to the native valve of the patient. Movement of thecap toward the coaption element causes the pair of paddles to move tothe closed position, and movement of the cap away from the coaptionelement causes the pair of paddles to move to the open position. The caphas a retention body for receiving attachment portions of the extensionmembers, a retaining nut, and a retaining bolt for securing theretaining nut.

An exemplary method of manufacturing a valve repair device for repairinga native valve of a patient includes: folding a strip of material toform a coaption element and a pair of paddles connected to the coaptionelement; attaching the portion of the strip of material forming thepaddles to a cap; attaching a pair of extension members to the retentionbody of the cap via attachment portions of the extension members suchthat the paddles are disposed over the extension members; and assemblingthe retaining bolt and retaining nut to secure the cap to the strip ofmaterial. The paddles are movable between an open position and a closedposition and are configured to attach to the native valve of thepatient. Movement of the cap toward the coaption element causes the pairof paddles to move to the closed position, and movement of the cap awayfrom the coaption element causes the pair of paddles to move to the openposition. The cap has a retention body for receiving attachment portionsof the extension members, a retaining nut, and a retaining bolt forsecuring the retaining nut.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of embodiments of the presentdisclosure, a more particular description of the certain embodimentswill be made by reference to various aspects of the appended drawings.It is appreciated that these drawings depict only typical embodiments ofthe present disclosure and are therefore not to be considered limitingof the scope of the disclosure. Moreover, while the figures can be drawnto scale for some embodiments, the figures are not necessarily drawn toscale for all embodiments. Embodiments and other features and advantagesof the present disclosure will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings in which:

FIG. 1 illustrates a cutaway view of the human heart in a diastolicphase;

FIG. 2 illustrates a cutaway view of the human heart in a systolicphase;

FIG. 2A is another cutaway view of the human heart in a systolic phase;

FIG. 2B is the cutaway view of FIG. 2A annotated to illustrate a naturalshape of mitral valve leaflets in the systolic phase;

FIG. 3 illustrates a cutaway view of the human heart in a diastolicphase, in which the chordae tendineae are shown attaching the leafletsof the mitral and tricuspid valves to ventricle walls;

FIG. 4 illustrates a healthy mitral valve with the leaflets closed asviewed from an atrial side of the mitral valve;

FIG. 5 illustrates a dysfunctional mitral valve with a visible gapbetween the leaflets as viewed from an atrial side of the mitral valve;

FIG. 6 illustrates a mitral valve having a wide gap between theposterior leaflet and the anterior leaflet;

FIG. 6A illustrates a coaption element in the gap of the mitral valve asviewed from an atrial side of the mitral valve;

FIG. 6B illustrates a valve repair device attached to mitral valveleaflets with the coaption element in the gap of the mitral valve asviewed from a ventricular side of the mitral valve;

FIG. 6C is a perspective view of a valve repair device attached tomitral valve leaflets with the coaption element in the gap of the mitralvalve shown from a ventricular side of the mitral valve;

FIG. 6D is a schematic view illustrating a path of mitral valve leafletsalong each side of a coaption element of mitral valve repair device;

FIG. 6E is a top schematic view illustrating a path of mitral valveleaflets around a coaption element of a mitral valve repair device;

FIG. 7 illustrates a tricuspid valve viewed from an atrial side of thetricuspid valve;

FIGS. 8-14 show an exemplary embodiment of an implantable prostheticdevice, in various stages of deployment;

FIG. 11A shows an exemplary embodiment of an implantable prostheticdevice that is similar to the device illustrated by FIG. 11, but wherethe paddles are independently controllable;

FIGS. 15-20 show the implantable prosthetic device of FIGS. 8-14 beingdelivered and implanted within the native mitral valve;

FIG. 21 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 22 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 23-25 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 23A shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 26 and 27 show an exemplary embodiment of a barbed clasp for usein an implantable prosthetic device;

FIGS. 28-32 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 30A shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 32A and 32B are perspective views of a cap and a coaption elementinsert of the implantable prosthetic device of FIGS. 28-32 in sealed andspaced apart positions, respectively;

FIG. 33 shows a barbed clasp for use in an implantable prostheticdevice;

FIG. 34 shows a portion of mitral valve tissue grasped by a barbedclasp;

FIGS. 35-46 show an exemplary embodiment of an implantable prostheticdevice being delivered and implanted within the native mitral valve;

FIG. 47 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a closed position;

FIG. 47A shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a closed position;

FIG. 48 shows a side view of an exemplary implantable prosthetic devicewith barbed clasps in a closed position;

FIG. 48A shows a side view of an exemplary implantable prosthetic devicewith barbed clasps in a closed position;

FIG. 48B shows a side view of an exemplary implantable prosthetic devicewith barbed clasps in a closed position, the device being attached to adeployment device;

FIG. 48C shows a side view of the exemplary implantable prostheticdevice according to FIG. 48B, the device being provided with a cover;

FIG. 48D shows a front view of the exemplary implantable prostheticdevice according to FIG. 48B, the device being attached to a deploymentdevice;

FIG. 48E shows a front view of the exemplary implantable prostheticdevice according to FIG. 48D, the device being provided with a cover;

FIG. 48F shows a side view of the exemplary implantable prostheticdevice according to FIG. 48B with barbed clasps in the closed position;

FIG. 48G shows a front view of the exemplary implantable prostheticdevice according to FIG. 48F;

FIG. 48H shows a top view of the exemplary implantable prosthetic deviceaccording to FIG. 48F;

FIG. 49 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a partially-open position;

FIG. 50 shows a side view of an exemplary implantable prosthetic devicein a partially-open position with barbed clasps in an open position;

FIG. 51 shows a side view of an exemplary implantable prosthetic devicein a partially-open position with barbed clasps in a closed position;

FIG. 52 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a half-open position;

FIG. 53 shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in a closed position;

FIG. 53A shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in a closed position;

FIG. 53B shows a front view of the exemplary implantable prostheticdevice according to FIG. 53A;

FIG. 53C shows a side view the exemplary implantable prosthetic deviceaccording to FIG. 53A, the device being provided with a cover;

FIG. 53D shows a front view the exemplary implantable prosthetic deviceaccording to FIG. 53A, the device being provided with a cover;

FIG. 54 shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in an open position;

FIG. 54A shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in an open position;

FIG. 54B shows a front view of the exemplary implantable prostheticdevice according to FIG. 54A;

FIG. 54C shows a side view the exemplary implantable prosthetic deviceaccording to FIG. 54A, the device being provided with a cover;

FIG. 54D shows a front view the exemplary implantable prosthetic deviceaccording to FIG. 54A, the device being provided with a cover;

FIG. 55 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a three-quarters-open position;

FIG. 56 shows a side view of an exemplary implantable prosthetic devicein a three-quarters-open position with barbed clasps in a closedposition;

FIG. 57 shows a side view of an exemplary implantable prosthetic devicein a three-quarters-open position with barbed clasps in an openposition;

FIG. 58 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps near a full bailout position;

FIG. 59 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a full bailout position;

FIG. 60 shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in a closed position;

FIG. 60A shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in a closed position;

FIG. 60B shows a front view of the exemplary implantable prostheticdevice according to FIG. 60A;

FIG. 60C shows a side view the exemplary implantable prosthetic deviceaccording to FIG. 60A, the device being provided with a cover;

FIG. 60D shows a front view the exemplary implantable prosthetic deviceaccording to FIG. 60A, the device being provided with a cover;

FIG. 61 shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in an open position;

FIG. 61A shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in an open position;

FIG. 61B shows a front view of the exemplary implantable prostheticdevice according to FIG. 61A;

FIG. 61C shows a side view the exemplary implantable prosthetic deviceaccording to FIG. 61A, the device being provided with a cover;

FIG. 61D shows a front view the exemplary implantable prosthetic deviceaccording to FIG. 61A, the device being provided with a cover;

FIGS. 62A-62B illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIGS. 63A-63C illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIGS. 64A-64C illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIG. 65 shows a perspective view of an exemplary implantable prostheticdevice in a closed position;

FIG. 65A shows a perspective view of an exemplary implantable prostheticdevice in a closed position;

FIG. 66 shows a perspective view of the implantable prosthetic device ofFIG. 65;

FIG. 66A shows a perspective view of the implantable prosthetic deviceof FIG. 65A;

FIG. 67 shows a front view of the implantable prosthetic device of FIG.65;

FIG. 67A shows a front view of the implantable prosthetic device of FIG.65A;

FIG. 68 shows a front view of the implantable prosthetic device of FIG.65 with additional components;

FIG. 68A shows a front view of the implantable prosthetic device of FIG.65A with additional components;

FIG. 69 shows a side view of the implantable prosthetic device of FIG.65;

FIG. 70 shows a top view of the implantable prosthetic device of FIG.65;

FIG. 70A shows a top view of the implantable prosthetic device of FIG.65A;

FIG. 71 shows a top view of the implantable prosthetic device of FIG. 65with a collar component;

FIG. 71A shows a top view of the implantable prosthetic device of FIG.65A with a collar component;

FIG. 72 shows a bottom view of the implantable prosthetic device of FIG.65;

FIG. 72A shows a bottom view of the implantable prosthetic device ofFIG. 65A;

FIG. 73 shows a bottom view of the implantable prosthetic device of FIG.65 with a cap component;

FIG. 73A shows a bottom view of the implantable prosthetic device ofFIG. 65A with a cap component;

FIG. 74 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 75;

FIG. 74A shows a sectioned perspective view of the implantableprosthetic device of FIG. 65A sectioned by cross-section plane 75A;

FIG. 75 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 74;

FIG. 75A shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 74A;

FIG. 76 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 77;

FIG. 76A shows a sectioned perspective view of the implantableprosthetic device of FIG. 65A sectioned by cross-section plane 77A;

FIG. 77 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 76;

FIG. 77A shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 76A;

FIG. 78 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 77;

FIG. 78A shows a sectioned perspective view of the implantableprosthetic device of FIG. 65A sectioned by cross-section plane 77A;

FIG. 79 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 78;

FIG. 79A shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 78A;

FIG. 80 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 81;

FIG. 80A shows a sectioned perspective view of the implantableprosthetic device of FIG. 65A sectioned by cross-section plane 81A;

FIG. 81 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 80;

FIG. 81A shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 80A;

FIG. 82 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 83;

FIG. 82A shows a sectioned perspective view of the implantableprosthetic device of FIG. 65A sectioned by cross-section plane 83A;

FIG. 83 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 82;

FIG. 83A shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 82A;

FIG. 84 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 85 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 86 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 86A shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 87 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 87A shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 88 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 88A shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 89 shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65;

FIG. 89A shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65A;

FIG. 90 shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65;

FIG. 90A shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65A;

FIG. 91 shows a front view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 91A shows a front view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65A;

FIG. 92 shows a side view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 92A shows a side view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65A;

FIG. 93 shows a top view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 93A shows a top view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65A;

FIG. 94 shows a bottom view of a coapting portion and portions of theimplantable prosthetic device illustrated by FIG. 65;

FIG. 94A shows a bottom view of a coapting portion and portions of theimplantable prosthetic device illustrated by FIG. 65A;

FIG. 95 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 96;

FIG. 95A shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65A with the section taken across plane 96A;

FIG. 96 shows a cross-section view of the coapting portion and paddleportions of FIG. 95;

FIG. 96A shows a cross-section view of the coapting portion and paddleportions of FIG. 95A;

FIG. 97 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 98;

FIG. 97A shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65A with the section taken across plane 98A;

FIG. 98 shows a cross-section view of the coapting portion and paddleportions of FIG. 97;

FIG. 98A shows a cross-section view of the coapting portion and paddleportions of FIG. 97A;

FIG. 99 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 100;

FIG. 99A shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65A with the section taken across plane 100A;

FIG. 100 shows a cross-section view of the coapting portion and paddleportions of FIG. 99;

FIG. 100A shows a cross-section view of the coapting portion and paddleportions of FIG. 99A;

FIG. 101 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 102;

FIG. 101A shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65A with the section taken across plane 102A;

FIG. 102 shows a cross-section view of the coapting portion and paddleportions of FIG. 101;

FIG. 102A shows a cross-section view of the coapting portion and paddleportions of FIG. 101A;

FIG. 103 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 104 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 105 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 106 shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106A shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106B shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106C shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106D shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106E shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106F shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106G shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106H shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106I shows an exemplary embodiment of an expandable coaptionelement;

FIG. 107 shows an end view of the expandable coaption element of FIG.106;

FIG. 108 shows the expandable coaption element of FIG. 106 in anexpanded condition;

FIG. 108A shows the expandable coaption element of FIG. 106A in anexpanded condition;

FIG. 108B shows the expandable coaption element of FIG. 106B in anexpanded condition;

FIG. 108C shows the expandable coaption element of FIG. 106C in anexpanded condition;

FIG. 108D shows the expandable coaption element of FIG. 106D in anexpanded condition;

FIG. 108E shows the expandable coaption element of FIG. 106E in anexpanded condition;

FIG. 109 shows an end view of the coaption element of FIG. 108;

FIG. 108 shows a side view of the coaption element for an exemplaryprosthetic device of FIG. 106 in a compressed condition;

FIG. 109 shows an end view of the coaption element of FIG. 108;

FIG. 110 shows a side view of an exemplary embodiment of an implantableprosthetic device;

FIG. 111 shows an end view of a coaption element of the exemplaryprosthetic device of FIG. 110, taken along lines 111.

FIGS. 112-114 show perspective views of an exemplary embodiment of apaddle frame for the implantable prosthetic device of FIG. 65;

FIG. 112A shows a perspective view of an exemplary embodiment of apaddle frame for the implantable prosthetic device of FIG. 65A;

FIG. 114A shows a side view of the paddle frame of FIG. 112A;

FIG. 115 shows a front view of the paddle frame of FIGS. 112-114;

FIG. 115A shows a top view of the paddle frame of FIG. 112A;

FIG. 116 shows a top view of the paddle frame of FIGS. 112-114;

FIG. 116A shows a front view of the paddle frame of FIG. 112A;

FIG. 117 shows a side view of the paddle frame of FIGS. 112-114;

FIG. 117A shows a rear view of the paddle frame of FIG. 112A;

FIG. 118 shows a bottom view of the paddle frame of FIGS. 112-114;

FIG. 118A shows a bottom view of the paddle frame of FIG. 112A;

FIG. 119 shows a front view of the paddle frame of FIGS. 112-114;

FIG. 120 shows a front view of the paddle frame of FIGS. 112-114 in acompressed condition inside a delivery device;

FIG. 121 shows a side view of an exemplary embodiment of an implantableprosthetic device in a closed condition;

FIG. 122 shows a front view of a paddle frame of the exemplaryprosthetic device of FIG. 121;

FIG. 123 shows a side view of the implantable prosthetic device of FIG.121 in a closed condition;

FIG. 124 shows a front view of the paddle frame of the open prostheticdevice of FIG. 123;

FIG. 125 shows a side view of an exemplary embodiment of an implantableprosthetic device in a closed condition;

FIG. 126 shows a front view of a paddle frame of the exemplaryprosthetic device of FIG. 125;

FIG. 127 shows a side view of the implantable prosthetic device of FIG.125 in a closed condition;

FIG. 128 shows a front view of the paddle frame of the open prostheticdevice of FIG. 127;

FIG. 129 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 130-131 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 132 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 133-134 show an exemplary embodiment of an implantable prostheticdevice;

FIGS. 135-136 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 137 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 138-143 show use of an exemplary embodiment of an implantableprosthetic device;

FIG. 144 shows an exemplary embodiment of a delivery assembly includinga delivery device and an exemplary prosthetic device;

FIG. 145 shows a perspective view of an exemplary embodiment of animplantable prosthetic device releasably coupled to a delivery device;

FIG. 146 shows the embodiment of FIG. 145 with the implantableprosthetic device released from to the delivery device;

FIG. 147 shows a cross-sectional view of the coupler of FIG. 145;

FIG. 148 shows a perspective view of the delivery assembly of FIG. 144with the prosthetic device shown in partial cross-section and somecomponents of the delivery apparatus shown schematically;

FIG. 149 shows a plan view of a shaft of the delivery device of FIG.144;

FIG. 150 shows a side elevation view of a proximal end portion of thedelivery device of FIG. 144;

FIG. 151 shows a cross-sectional view of the proximal end portion of thedelivery device of FIG. 144, taken along the line 150-150 shown in FIG.150;

FIG. 152 shows an exploded view of the proximal end portion of thedelivery device of FIG. 144;

FIGS. 153-160 show an exemplary procedure used to repair a native mitralvalve of a heart, which is partially shown;

FIG. 161 shows an exemplary embodiment of a handle for the deliveryapparatus of FIG. 144;

FIG. 162 is an exploded view of the handle of FIG. 161;

FIG. 163 shows an exemplary embodiment of a coupler and a proximalcollar for the delivery assembly of FIG. 144, showing the couplerreleasably coupled to the proximal collar;

FIG. 164 shows a perspective view of the coupler and proximal collar ofFIG. 163, showing the coupler released from the proximal collar;

FIG. 165 shows other exemplary embodiments of a cap, actuation shaft ormeans of actuating, and release wire for the delivery assembly of FIG.144, showing the cap releasably coupled to the actuation shaft or meansof actuating by the release wire.

FIG. 166 shows a perspective view of the cap, actuation shaft or meansof actuating, and the release wire of FIG. 163, showing the cap releasedfrom the actuation shaft or means of actuating and the release wire;

FIG. 167 shows other exemplary embodiments of a coupler, a proximalcollar, a cap, and an actuation shaft or means of actuating of thedelivery assembly of FIG. 144;

FIG. 168 shows a perspective view of the coupler and proximal collar ofFIG. 167;

FIG. 169 shows an exemplary embodiment of a clasp control member of thedelivery apparatus of FIG. 144;

FIG. 170 shows a detail view of the clasp control member of FIG. 169,taken from the perspective 170 shown in FIG. 169;

FIG. 171 shows an exemplary embodiment of a guide rail for the claspcontrol member of FIG. 169;

FIG. 172 shows an exemplary embodiment of a shaft of the delivery deviceof FIG. 144;

FIG. 173 shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIG. 174 shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIG. 174A shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIG. 175 shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIG. 175A shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIG. 176 shows an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIGS. 177-178 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 179-181 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 182-183 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 184-185 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIG. 186 shows an exemplary embodiment of an actuation shaft or means ofactuating for an exemplary prosthetic device;

FIG. 187 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 188 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 188A shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 189 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 190 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 191 is a perspective view of a blank used to make a paddle frame;

FIG. 192 is a perspective view of the blank of FIG. 191 bent to make apaddle frame;

FIG. 193 is a perspective view of a shape-set paddle frame attached to acap of a valve repair device;

FIG. 194 is a perspective view of the paddle frame of FIG. 193 flexedand attached to inner and outer paddles at a closed position;

FIG. 195 is a perspective view of two of the paddles frames of FIG. 112Ashowing the paddle frames in a shape-set position;

FIG. 196 is a perspective view of the paddle frames of FIG. 195 showingthe paddle frames in a loaded position;

FIG. 197 is an enlarged side view of device of FIG. 60C showing thecover;

FIG. 198 is an enlarged side view of the device of FIG. 60C showing thecover;

FIG. 199 shows an exploded view of an exemplary prosthetic device;

FIG. 200 shows an enlarged perspective view of the collar of anexemplary prosthetic device;

FIG. 201 shows an enlarged perspective view of the cap of an exemplaryprosthetic device;

FIG. 202 shows an exploded view of the cap of FIG. 206;

FIG. 203 shows a plan view of an inner cover for an exemplary prostheticdevice;

FIG. 204 shows a plan view of an outer cover for an exemplary prostheticdevice;

FIG. 205 shows an enlarged view of a strip of material for an exemplaryprosthetic device;

FIG. 206 shows an end view of the material of FIG. 205;

FIG. 207 shows an end view of the material of FIG. 205 arranged in aplurality of layers;

FIG. 208A shows an exemplary implantable prosthetic device in the gap ofthe mitral valve as viewed from an atrial side of the mitral valveduring diastole, with exemplary inflatable spacers in a deflatedcondition;

FIG. 208B shows the device of FIG. 208A during systole, with exemplaryinflatable spacers in a deflated condition;

FIG. 209A shows the device of FIG. 208A during diastole, with exemplaryinflatable spacers in an inflated condition;

FIG. 209B shows the device of FIG. 208A during systole, with exemplaryinflatable spacers in an inflated condition;

FIG. 210A shows an exemplary expandable spacer in a compressedcondition;

FIG. 210B shows the expandable spacer of FIG. 210A in an expandedcondition;

FIG. 211A shows an exemplary implantable prosthetic device, withexemplary inflatable spacers in a deflated condition;

FIG. 211B shows the device of FIG. 211B, with exemplary inflatablespacers in an inflated condition;

FIG. 212A is a side view of an exemplary implantable prosthetic device;

FIG. 212B is a front/back view of the device of FIG. 212A;

FIG. 213A is a top view of an exemplary auxiliary spacer for attachingto the device of FIG. 212A;

FIG. 213B is a side view of the spacer of FIG. 213A;

FIG. 214 is a side view of the spacer of FIGS. 213A, 213B beingassembled to the device of FIGS. 212A, 212B;

FIG. 215A is a side view of the spacer of FIGS. 213A, 213B assembled tothe device of FIGS. 212A, 212B;

FIG. 215B is a top view of the assembly of FIG. 215A;

FIG. 216A is a side view of an exemplary implantable prosthetic device;

FIG. 216B is a front/back view of the device of FIG. 216A;

FIG. 217A is a top view of an exemplary auxiliary spacer for attachingto the device of FIG. 216A;

FIG. 217B is a side view of the spacer of FIG. 217A;

FIG. 218 is an exemplary auxiliary spacer;

FIG. 219A is a top view of an exemplary implantable prosthetic device;

FIG. 219B is a side view of an exemplary implantable prosthetic device;

FIG. 220A is a top view of exemplary auxiliary spacers;

FIG. 220B is a top view of exemplary auxiliary spacers;

FIG. 220C is a top view of exemplary auxiliary spacers;

FIG. 220D is a top view of exemplary auxiliary spacers;

FIG. 220E is a top view of exemplary auxiliary spacers;

FIG. 221 is a plan view of an exemplary implantable prosthetic devicecut from a flat sheet of material;

FIG. 222 is a perspective view of the device of FIG. 221;

FIG. 223 shows the device of FIGS. 221-222 in the gap of the mitralvalve as viewed from an atrial side of the mitral valve;

FIG. 224 is a plan view of an exemplary implantable prosthetic devicecut from a flat sheet of material;

FIG. 225 is a perspective view of the device of FIG. 224;

FIG. 226 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover;

FIG. 227 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover;

FIG. 228 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover;

FIG. 229 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover;

FIG. 230 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover; and

FIG. 231 shows an exemplary embodiment of an implantable prostheticdevice with a two-piece cover.

DETAILED DESCRIPTION

The following description refers to the accompanying drawings, whichillustrate specific embodiments of the present disclosure. Otherembodiments having different structures and operation do not depart fromthe scope of the present disclosure.

Exemplary embodiments of the present disclosure are directed to devicesand methods for repairing a defective heart valve. It should be notedthat various embodiments of native valve reparation devices and systemsfor delivery are disclosed herein, and any combination of these optionscan be made unless specifically excluded. In other words, individualcomponents of the disclosed devices and systems can be combined unlessmutually exclusive or otherwise physically impossible.

As described herein, when one or more components are described as beingconnected, joined, affixed, coupled, attached, or otherwiseinterconnected, such interconnection may be direct as between thecomponents or may be indirect such as through the use of one or moreintermediary components. Also as described herein, reference to a“member,” “component,” or “portion” shall not be limited to a singlestructural member, component, or element but can include an assembly ofcomponents, members, or elements. Also as described herein, the terms“substantially” and “about” are defined as at least close to (andincludes) a given value or state (preferably within 10% of, morepreferably within 1% of, and most preferably within 0.1% of).

FIGS. 1 and 2 are cutaway views of the human heart H in diastolic andsystolic phases, respectively. The right ventricle RV and left ventricleLV are separated from the right atrium RA and left atrium LA,respectively, by the tricuspid valve TV and mitral valve MV; i.e., theatrioventricular valves. Additionally, the aortic valve AV separates theleft ventricle LV from the ascending aorta AA, and the pulmonary valvePV separates the right ventricle from the pulmonary artery PA. Each ofthese valves has flexible leaflets (e.g., leaflets 20, 22 shown in FIGS.4 and 5) extending inward across the respective orifices that cometogether or “coapt” in the flowstream to form the one-way,fluid-occluding surfaces. The native valve repair systems of the presentapplication are described primarily with respect to the mitral valve MV.Therefore, anatomical structures of the left atrium LA and leftventricle LV will be explained in greater detail. It should beunderstood that the devices described herein may also be used inrepairing other native valves, e.g., the devices can be used inrepairing the tricuspid valve TV, the aortic valve AV, and the pulmonaryvalve PV.

The left atrium LA receives oxygenated blood from the lungs. During thediastolic phase, or diastole, seen in FIG. 1, the blood that waspreviously collected in the left atrium LA (during the systolic phase)moves through the mitral valve MV and into the left ventricle LV byexpansion of the left ventricle LV. In the systolic phase, or systole,seen in FIG. 2, the left ventricle LV contracts to force the bloodthrough the aortic valve AV and ascending aorta AA into the body. Duringsystole, the leaflets of the mitral valve MV close to prevent the bloodfrom regurgitating from the left ventricle LV and back into the leftatrium LA, and blood is collected in the left atrium from the pulmonaryvein. In one exemplary embodiment, the devices described by the presentapplication are used to repair the function of a defective mitral valveMV. That is, the devices are configured to help close the leaflets ofthe mitral valve to prevent blood from regurgitating from the leftventricle LV and back into the left atrium LA. Unlike the prior art thatdescribes using sutures or clips often require multiple sutures or clipsand additional supports to treat large regurgitant, the devicesdescribed in the present application are designed to easily grasp andsecure the native leaflets around a coaption element that acts as afiller in the regurgitant orifice.

Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets,the anterior leaflet 20 and the posterior leaflet 22. The mitral valveMV also includes an annulus 24, which is a variably dense fibrous ringof tissues that encircles the leaflets 20, 22. Referring to FIG. 3, themitral valve MV is anchored to the wall of the left ventricle LV bychordae tendineae 10. The chordae tendineae 10 are cord-like tendonsthat connect the papillary muscles 12 (i.e., the muscles located at thebase of the chordae tendineae and within the walls of the leftventricle) to the leaflets 20, 22 of the mitral valve MV. The papillarymuscles 12 serve to limit the movements of the mitral valve MV andprevent the mitral valve from being reverted. The mitral valve MV opensand closes in response to pressure changes in the left atrium LA and theleft ventricle LV. The papillary muscles do not open or close the mitralvalve MV. Rather, the papillary muscles brace the mitral valve MVagainst the high pressure needed to circulate blood throughout the body.Together the papillary muscles and the chordae tendineae are known asthe subvalvular apparatus, which functions to keep the mitral valve MVfrom prolapsing into the left atrium LA when the mitral valve closes.

Various disease processes can impair proper function of one or more ofthe native valves of the heart H. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflammatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). In addition, damage to theleft ventricle LV or the right ventricle RV from prior heart attacks(i.e., myocardial infarction secondary to coronary artery disease) orother heart diseases (e.g., cardiomyopathy) can distort a native valve'sgeometry, which can cause the native valve to dysfunction. However, thevast majority of patients undergoing valve surgery, such as surgery tothe mitral valve MV, suffer from a degenerative disease that causes amalfunction in a leaflet (e.g., leaflets 20, 22) of a native valve(e.g., the mitral valve MV), which results in prolapse andregurgitation.

Generally, a native valve may malfunction in two different ways: (1)valve stenosis; and (2) valve regurgitation. Valve stenosis occurs whena native valve does not open completely and thereby causes anobstruction of blood flow. Typically, valve stenosis results frombuildup of calcified material on the leaflets of a valve, which causesthe leaflets to thicken and impairs the ability of the valve to fullyopen to permit forward blood flow.

The second type of valve malfunction, valve regurgitation, occurs whenthe leaflets of the valve do not close completely thereby causing bloodto leak back into the prior chamber (e.g., causing blood to leak fromthe left ventricle to the left atrium). There are three mechanisms bywhich a native valve becomes regurgitant—or incompetent—which includeCarpentier's type I, type II, and type III malfunctions. A Carpentiertype I malfunction involves the dilation of the annulus such thatnormally functioning leaflets are distracted from each other and fail toform a tight seal (i.e., the leaflets do not coapt properly). Includedin a type I mechanism malfunction are perforations of the leaflets, asare present in endocarditis. A Carpentier's type II malfunction involvesprolapse of one or more leaflets of a native valve above a plane ofcoaption. A Carpentier's type III malfunction involves restriction ofthe motion of one or more leaflets of a native valve such that theleaflets are abnormally constrained below the plane of the annulus.Leaflet restriction can be caused by rheumatic disease (Ma) or dilationof a ventricle (IIIb).

Referring to FIG. 4, when a healthy mitral valve MV is in a closedposition, the anterior leaflet 20 and the posterior leaflet 22 coapt,which prevents blood from leaking from the left ventricle LV to the leftatrium LA. Referring to FIG. 5, regurgitation occurs when the anteriorleaflet 20 and/or the posterior leaflet 22 of the mitral valve MV isdisplaced into the left atrium LA during systole. This failure to coaptcauses a gap 26 between the anterior leaflet 20 and the posteriorleaflet 22, which allows blood to flow back into the left atrium LA fromthe left ventricle LV during systole. As set forth above, there areseveral different ways that a leaflet (e.g. leaflets 20, 22 of mitralvalve MV) may malfunction, which can thereby lead to regurgitation.

Referring to FIG. 6, in certain situations, the mitral valve MV of apatient can have a wide gap 26 between the anterior leaflet 20 and theposterior leaflet 22 when the mitral valve is in a closed position(i.e., during the systolic phase). For example, the gap 26 can have awidth W between about 2.5 mm and about 17.5 mm, such as between about 5mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, suchas about 10 mm In some situations, the gap 3002 can have a width Wgreater than 15 mm. In any of the above-mentioned situations, a valverepair device is desired that is capable of engaging the anteriorleaflet 20 and the posterior leaflet 22 to close the gap 26 and preventregurgitation of blood through the mitral valve MV.

Although stenosis or regurgitation can affect any valve, stenosis ispredominantly found to affect either the aortic valve AV or thepulmonary valve PV, and regurgitation is predominantly found to affecteither the mitral valve MV or the tricuspid valve TV. Both valvestenosis and valve regurgitation increase the workload of the heart Hand may lead to very serious conditions if left un-treated; such asendocarditis, congestive heart failure, permanent heart damage, cardiacarrest, and ultimately death. Because the left side of the heart (i.e.,the left atrium LA, the left ventricle LV, the mitral valve MV, and theaortic valve AV) is primarily responsible for circulating the flow ofblood throughout the body, malfunction of the mitral valve MV or theaortic valve AV is particularly problematic and often life threatening.Accordingly, because of the substantially higher pressures on the leftside of the heart, dysfunction of the mitral valve MV or the aorticvalve AV is much more problematic.

Malfunctioning native heart valves may either be repaired or replaced.Repair typically involves the preservation and correction of thepatient's native valve. Replacement typically involves replacing thepatient's native valve with a biological or mechanical substitute.Typically, the aortic valve AV and pulmonary valve PV are more prone tostenosis. Because stenotic damage sustained by the leaflets isirreversible, the most conventional treatments for a stenotic aorticvalve or stenotic pulmonary valve are removal and replacement of thevalve with a surgically implanted heart valve, or displacement of thevalve with a transcatheter heart valve. The mitral valve MV and thetricuspid valve TV are more prone to deformation of leaflets, which, asdescribed above, prevents the mitral valve or tricuspid valve fromclosing properly and allows for regurgitation or back flow of blood fromthe ventricle into the atrium (e.g., a deformed mitral valve MV mayallow for regurgitation or back flow from the left ventricle LV to theleft atrium LA). The regurgitation or back flow of blood from theventricle to the atrium results in valvular insufficiency. Deformationsin the structure or shape of the mitral valve MV or the tricuspid valveTV are often repairable. In addition, regurgitation can occur due to thechordae tendineae 10 becoming dysfunctional (e.g., the chordae tendineaemay stretch or rupture), which allows the anterior leaflet 20 and theposterior leaflet 22 to be reverted such that blood is regurgitated intothe left atrium LA. The problems occurring due to dysfunctional chordaetendineae 10 can be repaired by repairing the chordae tendineae or thestructure of the mitral valve (e.g., by securing the leaflets 20, 22 atthe affected portion of the mitral valve).

The devices and procedures disclosed herein make reference to repairingthe structure of a mitral valve. However, it should be understood thatthe devices and concepts provided herein can be used to repair anynative valve, as well as any component of a native valve. Referring nowto FIG. 7, any of the devices and concepts provided herein can be usedto repair the tricuspid valve TV. For example, any of the devices andconcepts provided herein can be used between any two of the anteriorleaflet 30, septal leaflet 32, and posterior leaflet 34 to preventregurgitation of blood from the right ventricle into the right atrium.In addition, any of the devices and concepts provided herein can be usedon all three of the leaflets 30, 32, 34 together to preventregurgitation of blood from the right ventricle to the right atrium.That is, the valve repair devices provided herein can be centrallylocated between the three leaflets 30, 32, 34.

An exemplary implantable prosthetic device has a coaption element and atleast one anchor. The coaption element is configured to be positionedwithin the native heart valve orifice to help fill the space and form amore effective seal, thereby reducing or preventing regurgitationdescribed above. The coaption element can have a structure that isimpervious to blood and that allows the native leaflets to close aroundthe coaption element during ventricular systole to block blood fromflowing from the left or right ventricle back into the left or rightatrium, respectively. The prosthetic device can be configured to sealagainst two or three native valve leaflets; that is, the device may beused in the native mitral (bicuspid) and tricuspid valves. The coaptionelement is sometimes referred to herein as a spacer because the coaptionelement can fill a space between improperly functioning native mitral ortricuspid leaflets that do not close completely.

The coaption element can have various shapes. In some embodiments, thecoaption element can have an elongated cylindrical shape having a roundcross-sectional shape. In other embodiments, the coaption element canhave an oval cross-sectional shape, a crescent cross-sectional shape, orvarious other non-cylindrical shapes. The coaption element can have anatrial portion positioned in or adjacent to the left atrium, aventricular or lower portion positioned in or adjacent to the leftventricle, and a side surface that extends between the native mitralleaflets. In embodiments configured for use in the tricuspid valve, theatrial or upper portion is positioned in or adjacent to the rightatrium, and the ventricular or lower portion is positioned in oradjacent to the right ventricle, and the side surface that extendsbetween the native tricuspid leaflets.

The anchor can be configured to secure the device to one or both of thenative mitral leaflets such that the coaption element is positionedbetween the two native leaflets. In embodiments configured for use inthe tricuspid valve, the anchor is configured to secure the device toone, two, or three of the tricuspid leaflets such that the coaptionelement is positioned between the three native leaflets. In someembodiments, the anchor can attach to the coaption element at a locationadjacent the ventricular portion of the coaption element. In someembodiments, the anchor can attach to a shaft or actuation wire, towhich the coaption element is also attached. In some embodiments, theanchor and the coaption element can be positioned independently withrespect to each other by separately moving each of the anchor and thecoaption element along the longitudinal axis of the shaft or actuationwire. In some embodiments, the anchor and the coaption element can bepositioned simultaneously by moving the anchor and the coaption elementtogether along the longitudinal axis of the shaft or actuation wire. Theanchor can be configured to be positioned behind a native leaflet whenimplanted such that the leaflet is grasped by the anchor.

The prosthetic device can be configured to be implanted via a deliverysheath. The coaption element and the anchor can be compressible to aradially compressed state and can be self-expandable to a radiallyexpanded state when compressive pressure is released. The device can beconfigured for the anchor to be expanded radially away from thestill-compressed coaption element initially in order to create a gapbetween the coaption element and the anchor. A native leaflet can thenbe positioned in the gap. The coaption element can be expanded radially,closing the gap between the coaption element and the anchor andcapturing the leaflet between the coaption element and the anchor. Insome embodiments, the anchor and coaption element are optionallyconfigured to self-expand. The implantation methods for variousembodiments can be different and are more fully discussed below withrespect to each embodiment. Additional information regarding these andother delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S.Patent Application Publication Nos. 2014/0222136, and 2014/0067052,2016/0331523 each of which is incorporated herein by reference in itsentirety.

The disclosed prosthetic devices can be configured such that the anchoris connected to a leaflet, taking advantage of the tension from nativechordae tendineae to resist high systolic pressure urging the devicetoward the left atrium. During diastole, the devices can rely on thecompressive and retention forces exerted on the leaflet that is graspedby the anchor.

Referring now to FIGS. 8-14, a schematically illustrated implantableprosthetic device 100 is shown in various stages of deployment. Thedevice 100 can include any other features for an implantable prostheticdevice discussed in the present application, and the device 100 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The device 100 is deployed from a delivery sheath or means for delivery102 and includes a coaption portion 104 and an anchor portion 106. Thecoaption portion 104 of the device 100 includes a coaption element ormeans for coapting 110 that is adapted to be implanted between theleaflets of the native mitral valve and is slidably attached to anactuation wire or shaft 112. The anchor portion 106 is actuatablebetween open and closed conditions and can take a wide variety of forms,such as, for example, paddles, gripping elements, or the like. Actuationof the actuation wire or means for actuating 112 opens and closes theanchor portion 106 of the device 100 to grasp the mitral valve leafletsduring implantation. The actuation wire or shaft 112 may take a widevariety of different forms. For example, the actuation wire or shaft maybe threaded such that rotation of the actuation wire or shaft moves theanchor portion 106 relative to the coaption portion 104. Or, theactuation wire or shaft may be unthreaded, such that pushing or pullingthe actuation wire or shaft 112 moves the anchor portion 106 relative tothe coaption portion 104.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between a cap 114 and the coaptionelement or means for coapting 110 by portions 124, 126, 128. Theportions 124, 126, 128 may be jointed and/or flexible to move betweenall of the positions described below. The interconnection of the outerpaddles 120, the inner paddles 122, the coaption element or means forcoapting 110, and the cap 114 by the portions 124, 126, and 128 canconstrain the device to the positions and movements illustrated herein.

The actuation wire or means for actuating 112 extends through thedelivery sheath and the coaption element or means for coapting 110 tothe cap 114 at the distal connection of the anchor portion 106.Extending and retracting the actuation wire or means for actuating 112increases and decreases the spacing between the coaption element ormeans for coapting 110 and the cap 114, respectively. A collar removablyattaches the coaption element or means for coapting 110 to the deliverysheath or means for delivery 102 so that the actuation wire or means foractuating 112 slides through the collar and coaption element or meansfor coapting 110 during actuation to open and close the paddles 120, 122of the anchor portion 106.

Referring now to FIG. 11, the anchor portion 106 includes attachmentportions or gripping members. The illustrated gripping members arebarbed clasps 130 that include a base or fixed arm 132, a moveable arm134, barbs or means for securing 136, and a joint portion 138. The fixedarms 132 are attached to the inner paddles 122, with the joint portion138 disposed proximate the coaption element or means for coapting 110.The barbed clasps have flat surfaces and do not fit in a recess of thepaddle. Rather, the flat portions of the barbed clasps are disposedagainst the surface of the inner paddle 122. The joint portion 138provides a spring force between the fixed and moveable arms 132, 134 ofthe barbed clasp 130. The joint portion 138 can be any suitable joint,such as a flexible joint, a spring joint, a pivot joint, or the like. Incertain embodiments, the joint portion 138 is a flexible piece ofmaterial integrally formed with the fixed and moveable arms 132, 134.The fixed arms 132 are attached to the inner paddles 122 and remainstationary relative to the inner paddles 122 when the moveable arms 134are opened to open the barbed clasps 130 and expose the barbs or meansfor securing 136. The barbed clasps 130 are opened by applying tensionto actuation lines 116 attached to the moveable arms 134, therebycausing the moveable arms 134 to pivot on the joint portions 138.

During implantation, the paddles 120, 122 are opened and closed to graspthe native mitral valve leaflets between the paddles 120, 122 and thecoaption element or means for coapting 110. The barbed clasps 130further secure the native leaflets by engaging the leaflets with barbsor means for securing 136 and pinching the leaflets between the moveableand fixed arms 134, 132. The barbs or means for securing 136 of thebarbed clasps 130 increase friction with the leaflets or may partiallyor completely puncture the leaflets. The actuation lines 116 can beactuated separately so that each barbed clasp 130 can be opened andclosed separately. Separate operation allows one leaflet to be graspedat a time, or for the repositioning of a clasp 130 on a leaflet that wasinsufficiently grasped, without altering a successful grasp on the otherleaflet. The barbed clasps 130 can be opened and closed relative to theposition of the inner paddle 122 (as long as the inner paddle is in anopen position), thereby allowing leaflets to be grasped in a variety ofpositions as the particular situation requires.

The barbed clasps 130 can be opened separately by pulling on an attachedactuation line 116 that extends through the delivery sheath or means fordelivery 102 to the barbed clasp 130. The actuation line 116 can take awide variety of forms, such as, for example, a line, a suture, a wire, arod, a catheter, or the like. The barbed clasps 130 can be spring loadedso that in the closed position the barbed clasps 130 continue to providea pinching force on the grasped native leaflet. This pinching forceremains constant regardless of the position of the inner paddles 122.Barbs or means for securing 136 of the barbed clasps 130 can pierce thenative leaflets to further secure the native leaflets.

Referring now to FIG. 8, the device 100 is shown in an elongated orfully open condition for deployment from the delivery sheath. The device100 is loaded in the delivery sheath in the fully open position, becausethe fully open position takes up the least space and allows the smallestcatheter to be used (or the largest device 100 to be used for a givencatheter size). In the elongated condition the cap 114 is spaced apartfrom the coaption element or means for coapting 110 such that thepaddles 120, 122 of the anchor portion 106 are fully extended. In someembodiments, an angle formed between the interior of the outer and innerpaddles 120, 122 is approximately 180 degrees. The barbed clasps 130 arekept in a closed condition during deployment through the delivery sheathor means for delivery 102 so that the barbs or means for securing 136(FIG. 11) do not catch or damage the sheath or tissue in the patient'sheart.

Referring now to FIG. 9, the device 100 is shown in an elongateddetangling condition, similar to FIG. 8, but with the barbed clasps 130in a fully open position, ranging from about 140 degrees to about 200degrees, to about 170 degrees to about 190 degrees, or about 180 degreesbetween fixed and moveable portions of the barbed clasps 130. Fullyopening the paddles 120, 122 and the clasps 130 has been found toimprove ease of detanglement from anatomy of the patient duringimplantation of the device 100.

Referring now to FIG. 10, the device 100 is shown in a shortened orfully closed condition. The compact size of the device 100 in theshortened condition allows for easier maneuvering and placement withinthe heart. To move the device 100 from the elongated condition to theshortened condition, the actuation wire or means for actuating 112 isretracted to pull the cap 114 towards the coaption element or means forcoapting 110. The joints or flexible connections 126 between the outerpaddle 120 and inner paddle 122 are constrained in movement such thatcompression forces acting on the outer paddle 120 from the cap 114 beingretracted towards the coaption element or means for coapting 110 causethe paddles or gripping elements 120, 122 to move radially outward.During movement from the open to closed position, the outer paddles 120maintain an acute angle with the actuation wire or means for actuating112. The outer paddles 120 can optionally be biased toward a closedposition. The inner paddles 122 during the same motion move through aconsiderably larger angle as they are oriented away from the coaptionelement or means for coapting 110 in the open condition and collapsealong the sides of the coaption element or means for coapting 110 in theclosed condition. In certain embodiments, the inner paddles 122 arethinner and/or narrower than the outer paddles 120, and the joint orflexible portions 126, 128 connected to the inner paddles 122 can bethinner and/or more flexible. For example, this increased flexibilitycan allow more movement than the joint or flexible portion 124connecting the outer paddle 124 to the cap 114. In certain otherembodiments, the outer paddles 120 are narrower than the inner paddles122. The joint or flexible portions 126, 128 connected to the innerpaddles 122 can be more flexible, for example, to allow more movementthan the joint or flexible portion 124 connecting the outer paddle 124to the cap 114. In yet another embodiment, the inner paddles 122 can bethe same or substantially the same width as the outer paddles (See forexample, FIG. 65A).

Referring now to FIGS. 11-13, the device 100 is shown in a partiallyopen, grasp-ready condition. To transition from the fully closed to thepartially open condition, the actuation wire or means for actuating 112is extended to push the cap 114 away from the coaption element or meansfor coapting 110, thereby pulling on the outer paddles 120, which inturn pulls on the inner paddles 122, causing the anchor portion 106 topartially unfold. The actuation lines 116 are also retracted to open theclasps 130 so that the leaflets can be grasped. In the exampleillustrated by FIG. 11, the pair of inner and outer paddles 122, 120 aremoved in unison, rather than independently, by a single actuation wireor means for actuating 112. Also, the positions of the clasps 130 aredependent on the positions of the paddles 122, 120. For example,referring to FIG. 10 closing the paddles 122, 120 also closes theclasps.

FIG. 11A illustrates an exemplary embodiment where the paddles 120, 122are independently controllable. The device 100A illustrated by FIG. 11Ais similar to the device illustrated by FIG. 11, except the device 100Aincludes two independent actuation wires 112A, 112B that are coupled totwo independent caps 114A, 114B. To transition a first inner paddle anda first outer paddle from the fully closed to the partially opencondition, the actuation wire or means for actuating 112A is extended topush the cap 114A away from the coaption element or means for coapting110, thereby pulling on the outer paddle 120, which in turn pulls on theinner paddle 122, causing the first anchor portion 106 to partiallyunfold. To transition a second inner paddle and a second outer paddlefrom the fully closed to the partially open condition, the actuationwire or means for actuating 112B is extended to push the cap 114 awayfrom the coaption element or means for coapting 110, thereby pulling onthe outer paddle 120, which in turn pulls on the inner paddle 122,causing the second anchor portion 106 to partially unfold. Theindependent paddle control illustrated by FIG. 11A can be implemented onany of the devices disclosed by the present application.

Referring now to FIG. 12, one of the actuation lines 116 is extended toallow one of the clasps 130 to close. Referring now to FIG. 13, theother actuation line 116 is extended to allow the other clasp 130 toclose. Either or both of the actuation lines 116 may be repeatedlyactuated to repeatedly open and close the barbed clasps 130.

Referring now to FIG. 14, the device 100 is shown in a fully closed anddeployed condition. The delivery sheath or means for delivery 102 andactuation wire or means for actuating 112 are retracted and the paddles120, 122 and clasps 130 remain in a fully closed position. Oncedeployed, the device 100 may be maintained in the fully closed positionwith a mechanical latch or may be biased to remain closed through theuse of spring materials, such as steel, other metals, plastics,composites, etc. or shape-memory alloys such as Nitinol. For example,the jointed or flexible portions 124, 126, 128, 138, and/or the innerand outer paddles 122, and/or an additional biasing component (seecomponent 524 in FIG. 28) may be formed of metals such as steel orshape-memory alloy, such as Nitinol—produced in a wire, sheet, tubing,or laser sintered powder—and are biased to hold the outer paddles 120closed around the coaption element or means for coapting 110 and thebarbed clasps 130 pinched around native leaflets. Similarly, the fixedand moveable arms 132, 134 of the barbed clasps 130 are biased to pinchthe leaflets. In certain embodiments, the joint portions 124, 126, 128,138, and/or the inner and outer paddles 122, and/or an additionalbiasing component (see component 524 in FIG. 28) may be formed of anyother suitably elastic material, such as a metal or polymer material, tomaintain the device in the closed condition after implantation.

Referring now to FIGS. 226-231, the implantable device 100 is shownprovided with a cover 140. The cover 140 can be a cloth material such aspolyethylene cloth of a fine mesh. The cloth cover can provide a bloodseal on the surface of the spacer, and/or promote rapid tissue ingrowth.The cover 140 includes first and second cover portions 142, 144 thateach cover different portions of the device 100. In some embodiments, aportion of one of the first and second cover portions 142, 144 overlapsa portion of the other of the first and second cover portion 142, 144.The first and second cover portions 142, 144 can be arranged in variousways, and in some embodiments, can include an overlapping portion 146that overlaps one of the first and second cover portions 142, 144.

Referring now to FIGS. 226-229, various arrangements of the first andsecond cover portions 142, 144 are shown without overlapping portions146. Referring now to FIG. 226, the first cover portion 142 extends fromthe cap 114 to cover the cap 114, outer paddles 120, inner paddles 122,and the fixed arms 132 of the clasps 130. The second cover 144 coversthe coaption element or means for coapting 110. Referring now to FIG.227, the first cover portion 142 extends from the cap 114 to cover thecap 114, outer paddles 120, inner paddles 122, and the fixed arms 132and moveable arms 134 of the clasps 130. As with the cover 140 of FIG.226, the second cover 144 covers the coaption element or means forcoapting 110. Referring now to FIG. 228, the first cover portion 142extends from the cap 114 to cover the cap 114, outer paddles 120, innerpaddles 122, and the fixed arms 132 of the clasps 130. The second cover144 covers the coaption element or means for coapting 110 and extendsfrom the coaption element or means for coapting 110 to cover themoveable arms 134 of the clasps 130. Referring now to FIG. 229, thefirst cover portion 142 extends from the cap 114 to cover the cap 114and outer paddles 120. The second cover 144 covers the coaption elementor means for coapting 110 and extends from the coaption element or meansfor coapting 110 to cover the inner paddles 122, and the fixed arms 132and moveable arms 134 of the clasps 130.

Referring now to FIGS. 230-231, arrangements of the first and secondcover portions 142,144 are shown that include an overlapping portion146. Referring now to FIG. 230, the first cover portion 142 extends fromthe cap 114 to cover the cap 114, outer paddles 120, inner paddles 122,and the fixed arms 132 and moveable arms 134 of the clasps 130. Thesecond cover 144 covers the coaption element or means for coapting 110and includes overlapping portions 146 that extend from the coaptionelement or means for coapting 110 to overlap a portion of the moveablearms 134 that are covered by the first cover 142. Referring now to FIG.231, the first cover portion 142 extends from the cap 114 to cover thecap 114, outer paddles 120, inner paddles 122, and the fixed arms 132 ofthe clasps 130. The second cover 144 covers the coaption element ormeans for coapting 110 and moveable arms 134 of the clasps 130. Thefirst cover 142 also includes overlapping portions 146 that extend fromthe fixed arms 132 and inner paddles 122 to overlap a portion of themoveable arms 134 and coaption element or means for coapting 110 thatare covered by the second cover 144.

Referring now to FIGS. 15-20, the implantable device 100 of FIGS. 8-14is shown being delivered and implanted within the native mitral valve MVof the heart H. Referring now to FIG. 15, the delivery sheath isinserted into the left atrium LA through the septum and the device 100is deployed from the delivery sheath in the fully open condition. Theactuation wire or means for actuating 112 is then retracted to move thedevice 100 into the fully closed condition shown in FIG. 16. As can beseen in FIG. 17, the device 100 is moved into position within the mitralvalve MV into the ventricle LV and partially opened so that the leaflets20,22 can be grasped. Referring now to FIG. 18, an actuation line 116 isextended to close one of the clasps 130, capturing a leaflet 20. FIG. 19shows the other actuation line 116 being then extended to close theother clasp 130, capturing the remaining leaflet 22. Lastly, as can beseen in FIG. 20, the delivery sheath or means for delivery 102 andactuation wire or means for actuating 112 and actuation lines 116 arethen retracted and the device 100 is fully closed and deployed in thenative mitral valve MV.

Referring now to FIG. 21, an implantable prosthetic device 200 is shown.The device 200 includes an annular spacer member 202, a fabric cover(not shown), and anchors 204 extending from the spacer member 202. Theends of each anchor 204 can be coupled to respective struts of thespacer member 202 by respective sleeves 206 that can be crimped orwelded around the connection portions of the anchors 206 and the strutsof the spacer member 202. In another exemplary embodiment, a latchingmechanism can bind the spacer member 202 to the anchor 204 within thesleeve 206. For example, the sleeve can be machined to have an interiorshape that matches or is slightly smaller than the exterior shape of theends of the spacer member 202 and the anchor 204, so that the sleeve canbe friction fit on the connection portions. One or more barbs orprojections 208 can be mounted on the frame of the spacer member 202.The free ends of the barbs or projections 208 can comprise variousshapes including rounded, pointed, barbed, or the like. The projections208 can exert a retaining force against native leaflets by virtue of theanchors 204, which are shaped to force the native leaflets inwardly intothe spacer member 202.

Referring now to FIG. 22, an implantable prosthetic device 300 is shown.The prosthetic spacer device 300 includes an annular spacer member 302,a fabric cover (not shown), and anchors 304 extending from the spacermember 302 and can be configured similar to the prosthetic spacer device200. One or more barbs or projections 306 can be mounted on the frame ofthe spacer member 302. The ends of the projections 306 can comprisestoppers 308. The stoppers 308 of the projections can be configured in awide variety of different ways. For example, the stoppers 308 can beconfigured to limit the extent of the projections 306 that can engageand/or penetrate the native leaflets and/or the stoppers can beconfigured to prevent removal of the projections 306 from the tissueafter the projections 306 have penetrated the tissue.

The anchors 304 of the prosthetic spacer device 300 can be configuredsimilar to the anchors 204 of the prosthetic spacer device 200 exceptthat the curve of each anchor 304 comprises a larger radius than theanchors 204. As such, the anchors 304 cover a relatively larger portionof the spacer member 302 than the anchors 204. This can, for example,distribute the clamping force of the anchors 304 against the nativeleaflets over a relatively larger surface of the native leaflets inorder to further protect the native leaflet tissue.

Additional details regarding the prosthetic spacer devices can be found,for example, in U.S. Patent Application Publication No. 2016/0331523 andU.S. Provisional Application No. 62/161,688, which applications areincorporated by reference herein. The devices 200, 300 can include anyother features for an implantable prosthetic device discussed in thepresent application, and the device 200, 300 can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

Referring now to FIGS. 23-27, an exemplary embodiment of an implantableprosthetic spacer device 400 is shown. The device 400 can include anyother features for an implantable prosthetic device discussed in thepresent application, and the device 400 can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

Referring now to FIG. 23, the prosthetic spacer or coaption device 400can include a coaption portion 404 and an anchor portion 406, the anchorportion 406 including a plurality of anchors 408. The coaption portion404 includes a coaption or spacer member 410. The anchor portion 406includes a plurality of paddles 420 (e.g., two in the illustratedembodiment), and a plurality of clasps 430 (e.g., two in the illustratedembodiment). A first or proximal collar 411, and a second collar or cap414 are used to move the coaption portion 404 and the anchor portion 406relative to one another.

As shown in FIG. 25, first connection portions 425 of the anchors 408can be coupled to and extend from a first portion 417 of the coaption orspacer member 410, and second connection portions 421 of the anchors 408can be coupled to the first collar 414. The proximal collar 411 can becoupled to a second portion 419 of the coaption member 410.

The coaption member 410 and the anchors 408 can be coupled together invarious ways. For example, as shown in the illustrated embodiment, thecoaption member 410 and the anchors 408 can be coupled together byintegrally forming the coaption member 410 and the anchors 408 as asingle, unitary component. This can be accomplished, for example, byforming the coaption member 410 and the anchors 408 from a braided orwoven material, such as braided or woven nitinol wire. In otherembodiments, the coaption member 410 and the anchors 408 can be coupledtogether by welding, fasteners, adhesive, joint connections, sutures,friction fittings, swaging, and/or other means for coupling.

Referring now to FIG. 24, the anchors 408 can comprise first portions orouter paddles 420 and second portions or inner paddles 422 separated byjoint portions 423. In this manner, the anchors 408 are configuredsimilar to legs in that the inner paddles 422 are like upper portions ofthe legs, the outer paddles 420 are like lower portions of the legs, andthe joint portions 423 are like knee portions of the legs. In theillustrated example, the inner paddle portion 422, the outer paddleportion 420, and the joint portion 423 are formed from a continuousstrip of fabric, such as a metal fabric.

The anchors 408 can be configured to move between various configurationsby axially moving the cap 414 relative to the proximal collar 411 andthus the anchors 408 relative to the coaption member 410 along alongitudinal axis extending between the first or distal and second orproximal portions 417, 419 of the coaption member 410. For example, theanchors 408 can be positioned in a straight configuration by moving thecap 414 away from the coaption member 410. In the straightconfiguration, the paddle portions are aligned or straight in thedirection of the longitudinal axis of the device and the joint portions423 of the anchors 408 are adjacent the longitudinal axis of thecoaption member 410 (e.g., similar to the configuration shown in FIG.59). From the straight configuration, the anchors 408 can be moved to afully folded configuration (e.g., FIG. 23) by moving the toward thecoaption member 410. Initially as the cap 414 moves toward the coaptionmember 410, the anchors 408 bend at the joint portions 423, 425, 421 andthe joint portions 423 move radially outwardly relative to thelongitudinal axis of the coaption member 410 and axially toward thefirst portion 414 of the coaption member 410, as shown in FIGS. 24-25.As the cap 414 continues to move toward the coaption member 410, thejoint portions 423 move radially inwardly relative to the longitudinalaxis of the coaption member 410 and axially toward the proximal portion419 of the coaption member 410, as shown in FIG. 23.

In some embodiments, an angle between the inner paddles 422 of theanchors 408 and the coaption member 410 can be approximately 180 degreeswhen the anchors 408 are in the straight configuration (see, e.g., FIG.59), and the angle between the inner paddles 422 of the anchors 408 andthe coaption member 410 can be approximately 0 degrees when the anchors408 are in the fully folded configuration (See FIG. 23). The anchors 408can be positioned in various partially folded configurations such thatthe angle between the inner paddles 422 of the anchors 408 and thecoaption member 410 can be approximately 10-170 degrees or approximately45-135 degrees.

Configuring the prosthetic spacer device 400 such that the anchors 408can extend to a straight or approximately straight configuration (e.g.approximately 120-180 degrees relative to the coaption member 410) canprovide several advantages. For example, this can reduce the radialcrimp profile of the prosthetic spacer device 400. It can also make iteasier to grasp the native leaflets by providing a larger opening inwhich to grasp the native leaflets. Additionally, the relatively narrow,straight configuration can prevent or reduce the likelihood that theprosthetic spacer device 400 will become entangled in native anatomy(e.g., chordae tendineae) when positioning and/or retrieving theprosthetic spacer device 400 into the delivery apparatus.

Referring again to FIG. 24, the clasps 430 can comprise attachment orfixed portions 432 and arm or moveable portions 434. The attachment orfixed portions 432 can be coupled to the inner paddles 422 of theanchors 408 in various ways such as with sutures, adhesive, fasteners,welding, stitching, swaging, friction fit and/or other means forcoupling.

The moveable portions 434 can pivot relative to the fixed portions 432between an open configuration (e.g., FIGS. 24) and a closedconfiguration (FIGS. 23 and 25). In some embodiments, the clasps 430 canbe biased to the closed configuration. In the open configuration, thefixed portions 432 and the moveable portions 434 pivot away from eachother such that native leaflets can be positioned between the fixedportions 432 and the moveable portions 434. In the closed configuration,the fixed portions 432 and the moveable portions 434 pivot toward eachother, thereby clamping the native leaflets between the fixed portions432 and the moveable portions 434.

Referring to FIGS. 26-27, clasps 430 are shown in top and perspectiveviews. The fixed portions 432 (only one shown in FIGS. 26-27) cancomprise one or more openings 433 (e.g., three in the illustratedembodiment). At least some of the openings 433 can be used to couple thefixed portions 432 to the anchors 408. For example, sutures and/orfasteners can extend through the openings 433 to couple the fixedportions 432 to the anchors 408 or other attachments, such as welding,adhesives, etc. can be used.

The moveable portions 434 can comprise one or more side beams 431. Whentwo side beams are included as illustrated, the side beams can be spacedapart to form slots 431A. The slots 431A can be configured to receivethe fixed portions 432. The moveable portions 434 can also includespring portions 434A that are coupled to the fixed portions 432 and barbsupport portions 434B disposed opposite the spring portions 434A.

The barb support portions 434B can comprise gripper or attachmentelements such as barbs 436 and/or other means for frictionally engagingnative leaflet tissue. The gripper elements can be configured to engageand/or penetrate the native leaflet tissue to help retain the nativeleaflets between the fixed portions 432 and moveable portions 434 of theclasps 430.

The barb support portions 434B can also comprise eyelets 435, which canbe used to couple the barb support portions 434B to an actuationmechanism configured to pivot the moveable portions 434 relative to thefixed portions 432. Additional details regarding coupling the clasps 430to the actuation mechanism are provided below.

In some embodiments, the clasps 430 can be formed from a shape memorymaterial such as nitinol, stainless steel, and/or shape memory polymers.In certain embodiments, the clasps 430 can be formed by laser-cutting apiece of flat sheet material (e.g., nitinol) or a tube in theconfiguration shown in FIG. 26 or a similar or different configurationand then shape-setting the clasp 430 in the configuration shown in FIG.27.

Shape-setting the clasps 430 in this manner can provide severaladvantages. For example, the clasps 430 can optionally be compressedfrom the shape-set configuration (e.g., FIG. 27) to the flatconfiguration (e.g., FIG. 26), or another configuration which reducesthe radial crimp profile of the clasps 430. For example, the barbs canoptionally be compressed to a flat configuration. Reducing the radialcrimp profile can improve trackability and retrievability of theprosthetic spacer device 400 relative to a catheter shaft of a deliveryapparatus because barbs 440 are pointing radially inwardly toward theanchors 408 when the prosthetic spacer device 400 is advanced through orretrieved into the catheter shaft (see, e.g., FIG. 33). This can preventor reduce the likelihood that the clasps 430 may snag or skive thecatheter shaft.

In addition, shape-setting the clasps 430 in the configuration shown inFIG. 27 can increase the clamping force of the clasps 430 when theclasps 430 are in the closed configuration. This is because the moveableportions 434 are shape-set relative to the fixed portions 432 to a firstposition (e.g., FIG. 27) which is beyond the position the moveableportions 434 can achieve when the clasps 430 are attached to the anchors408 (e.g., FIG. 25) because the anchors 408 prevent the moveableportions 434 from further movement toward the shape-set configuration.This results in moveable portions 434 having a preload (i.e., theclamping force is greater than zero) when the clasps 430 are attached tothe anchors 408 and in the closed configuration. Thus, shape-setting theclasps 430 in the FIG. 27 configuration can increase the clamping forceof the clasps 430 compared to clasps that are shape-set in the closedconfiguration.

The magnitude of the preload of the clasps 430 can be altered byadjusting the angle in which the moveable portions 434 are shape-setrelative to the fixed portions 432. For example, increasing the relativeangle between the moveable portions 434 and the fixed portions 432increases the preload, and decreasing the relative angle between themoveable portions 434 and the fixed portions 432 decreases the preload.

In some embodiments, the proximal collar 411 and/or the coaption member410 can comprise a hemostatic seal 413 configured to reduce or preventblood from flowing through the proximal collar 411 and/or the coaptionmember 410. For example, in some embodiments, the hemostatic seal 413can comprise a plurality of flexible flaps 413A, as shown in FIG. 23.The flaps 413A can be configured to pivot from a sealed configuration toan open configuration to allow a shaft of a delivery apparatus to extendthrough the second collar 410. In one exemplary embodiment, the flaps413A form a seal around the shaft of the delivery apparatus. When theshaft of the delivery apparatus is removed, the flaps 413A can beconfigured to return to the sealed configuration from the openconfiguration.

Referring now to FIG. 23A, an exemplary embodiment of an implantableprosthetic spacer device 400A is shown. The device 400A can include anyother features for an implantable prosthetic device discussed in thepresent application, and the device 400A can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

The prosthetic spacer or coaption device 400A can include a coaptionportion 404A and an anchor portion 406A, the anchor portion 406Aincluding a plurality of anchors 408A. The coaption portion 404Aincludes a coaption member or spacer 410A. The anchor portion 406Aincludes a plurality of paddles 420A (e.g., two in the illustratedembodiment), and a plurality of clasps 430A (e.g., two in theillustrated embodiment). A first or proximal collar 411A, and a secondcollar or cap 414A are used to move the coaption portion 404A and theanchor portion 406A relative to one another.

The coaption member 410A extends from a proximal portion 419A assembledto the collar 411A to a distal portion 417A that connects to the anchors408A. The coaption member 410A and the anchors 408A can be coupledtogether in various ways. For example, as shown in the illustratedembodiment, the coaption member 410A and the anchors 408A can be coupledtogether by integrally forming the coaption member 410A and the anchors408A as a single, unitary component. This can be accomplished, forexample, by forming the coaption member 410A and the anchors 408A from acontinuous strip 401A of a braided or woven material, such as braided orwoven nitinol wire.

The anchors 408A are attached to the coaption member 410A by hingeportions 425A and to the cap 414A by hinge portions 421A. The anchors408A can comprise first portions or outer paddles 420A and secondportions or inner paddles 422A separated by joint portions 423A. Thejoint portions 423A are attached to paddle frames 424A that arehingeably attached to the cap 414A. In this manner, the anchors 408A areconfigured similar to legs in that the inner paddles 422A are like upperportions of the legs, the outer paddles 420A are like lower portions ofthe legs, and the joint portions 423A are like knee portions of thelegs. In the illustrated example, the inner paddle portion 422A, theouter paddle portion 420A, and the joint portion 423A are formed fromthe continuous strip of fabric 401A, such as a metal fabric.

The anchors 408A can be configured to move between variousconfigurations by axially moving the cap 414A relative to the proximalcollar 411A and thus the anchors 408A relative to the coaption member410A along a longitudinal axis extending between the cap 414A and theproximal collar 411A. For example, the anchors 408 can be positioned ina straight configuration (see FIG. 60A) by moving the cap 414A away fromthe coaption member 410A. In the straight configuration, the paddleportions 420A, 422A are aligned or straight in the direction of thelongitudinal axis of the device and the joint portions 423A of theanchors 408A are adjacent the longitudinal axis of the coaption member410A (e.g., similar to the configuration shown in FIG. 60A). From thestraight configuration, the anchors 408 can be moved to a fully foldedconfiguration (e.g., FIG. 23A) by moving the toward the coaption member410A. Initially, as the cap 414A moves toward the coaption member 410A,the anchors 408A bend at joint portions 421A, 423A, 425A, and the jointportions 423A move radially outwardly relative to the longitudinal axisof the device 400A and axially toward the distal portion 417A of thecoaption member 410A, as shown in FIGS. 53A and 54A. As the cap 414Acontinues to move toward the coaption member 410A, the joint portions423A move radially inwardly relative to the longitudinal axis of thedevice 400A and axially toward the proximal portion 419A of the coaptionmember 410A, as shown in FIG. 23A.

In some embodiments, an angle between the inner paddles 422A of theanchors 408A and the coaption member 410A can be approximately 180degrees when the anchors 408A are in the straight configuration (see,e.g., FIG. 60A), and the angle between the inner paddles 422A of theanchors 408A and the coaption member 410A can be approximately 0 degreeswhen the anchors 408A are in the fully folded configuration (see FIG.23A). The anchors 408A can be positioned in various partially foldedconfigurations such that the angle between the inner paddles 422A of theanchors 408A and the coaption member 410A can be approximately 10-170degrees or approximately 45-135 degrees.

Configuring the prosthetic spacer device 400A such that the anchors 408Acan extend to a straight or approximately straight configuration (e.g.approximately 120-180 degrees relative to the coaption member 410A) canprovide several advantages. For example, this can reduce the radialcrimp profile of the prosthetic spacer device 400A. It can also make iteasier to grasp the native leaflets by providing a larger opening inwhich to grasp the native leaflets. Additionally, the relatively narrow,straight configuration can prevent or reduce the likelihood that theprosthetic spacer device 400A will become entangled in native anatomy(e.g., chordae tendineae) when positioning and/or retrieving theprosthetic spacer device 400A into the delivery apparatus.

The clasps 430A can comprise attachment or fixed portions 432C and armor moveable portions 434C. The attachment or fixed portions 432C can becoupled to the inner paddles 422A of the anchors 408A in various wayssuch as with sutures, adhesive, fasteners, welding, stitching, swaging,friction fit and/or other means for coupling. The clasps 430A aresimilar to the clasps 430.

The moveable portions 434C can pivot relative to the fixed portions 432Cbetween an open configuration (e.g., FIG. 54A) and a closedconfiguration (FIGS. 53A). In some embodiments, the clasps 430A can bebiased to the closed configuration. In the open configuration, the fixedportions 432C and the moveable portions 434C pivot or flex away fromeach other such that native leaflets can be positioned between the fixedportions 432C and the moveable portions 434C. In the closedconfiguration, the fixed portions 432C and the moveable portions 434Cpivot or flex toward each other, thereby clamping the native leafletsbetween the fixed portions 432C and the moveable portions 434C.

The strip 401A is attached the collar 411A, cap 414A, paddle frames424A, clasps 430A to form both the coaption portion 404A and the anchorportion 406A of the device 400A. In the illustrated embodiment, thecoaption member 410A, hinge portions 421A, 423A, 425A, outer paddles420A, and inner paddles 422A are formed from the continuous strip 401A.The continuous strip 401A may be a single layer of material or mayinclude two or more layers. In certain embodiments, portions of thedevice 400A have a single layer of the strip of material 401A and otherportions are formed from multiple overlapping or overlying layers of thestrip of material 401A. For example, FIG. 23A shows the coaption member410A and inner paddles 422A formed from multiple overlapping layers ofthe strip of material 401A. The single continuous strip of material 401Acan start and end in various locations of the device 400A. The ends ofthe strip of material 401A can be in the same location or differentlocations of the device 400A. For example, in the illustrated embodimentof FIG. 23A, the strip of material begins and ends in the location ofthe inner paddles 422A.

Referring now to FIG. 30A, the exemplary implantable prosthetic device400A is shown covered with a cover 440A. The cover 440A is disposed onthe coaption member 410A, the collar 411A, the cap 414A, the paddles420A, 422A, the paddle frames 424A, and the clasps 430A. The cover 440Acan be configured to prevent or reduce blood-flow through the prostheticspacer device 400A and/or to promote native tissue ingrowth. In someembodiments, the cover 440A can be a cloth or fabric such as PET,velour, or other suitable fabric. In other embodiments, in lieu of or inaddition to a fabric, the cover 440A can include a coating (e.g.,polymeric material) that is applied to the prosthetic spacer device400A.

Referring now to FIGS. 28-30, an exemplary embodiment of an implantableprosthetic spacer device 500 is shown. The implantable device 500 is oneof the many different configurations that the device 100 that isschematically illustrated in FIGS. 8-20 can take. The device 500 caninclude any other features for an implantable prosthetic devicediscussed in the present application, and the device 500 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The prosthetic spacer device 500 can comprise a coaption element orspacer member 510, a plurality of anchors 508 that include outer paddles520, inner paddles 522, clasps 530, a first or proximal collar 511, anda second collar or cap 514. These components of the prosthetic spacerdevice 500 can be configured substantially similar to the correspondingcomponents of the prosthetic spacer device 400.

The prosthetic spacer device 500 can also include a plurality of paddleextension members or paddle frames 524. The paddle frames 524 can beconfigured with a round three-dimensional shape with first connectionportions 526 coupled to and extending from the cap 514 and secondconnection portions 528 disposed opposite the first connection portions526. The paddle frames 524 can be configured to extend circumferentiallyfarther around the coaption member 510 than the outer paddles 520. Forexample, in some embodiments, each of the paddle frames 524 can extendaround approximately half of the circumference of the coaption member510 (as shown in FIG. 29), and the outer paddles 520 can extend aroundless than half of the circumference of the coaption member 510 (as shownin FIG. 28). The paddle frames 524 can also be configured to extendlaterally (i.e., perpendicular to a longitudinal axis of the coaptionmember 510) beyond an outer diameter of the coaption member 510. In theillustrated example, the inner paddle portions 522 and the outer paddleportions 520 are formed from a continuous strip of fabric that areconnected to the paddle frames 524. For example, the inner paddleportions and the outer paddle portions can be connected to theconnection portion of the paddle frame at the flexible connectionbetween the inner paddle portion and the outer paddle portion.

The paddle frames 524 can further be configured such that connectionportions 528 of the paddle frames 524 are connected to or axiallyadjacent a joint portion 523. The connection portions of the paddleframes 534 can be positioned between outer and inner paddles 520, 522,on the outside of the paddle portion 520, on the inside of the innerpaddle portion, or on top of the joint portion 523 when the prostheticspacer device 500 is in a folded configuration (e.g., FIGS. 28-30). Theconnections between the paddle frames 524, the single strip that formsthe outer and inner paddles 520, 522, the cap 514, and the coaptionelement can constrain each of these parts to the movements and positionsdescribed herein. In particular the joint portion 523 is constrained byits connection between the outer and inner paddles 520, 522 and by itsconnection to the paddle frame. Similarly, the paddle frame 524 isconstrained by its attachment to the joint portion 523 (and thus theinner and outer paddles) and to the cap.

Configuring the paddle frames 524 in this manner provides increasedsurface area compared to the outer paddles 520 alone. This can, forexample, make it easier to grasp and secure the native leaflets. Theincreased surface area can also distribute the clamping force of thepaddles 520 and paddle frames 524 against the native leaflets over arelatively larger surface of the native leaflets in order to furtherprotect the native leaflet tissue.

The increased surface area of the paddle frames 524 can also allow thenative leaflets to be clamped to the prosthetic spacer device 500, suchthat the native leaflets coapt entirely around the coaption member 510.This can, for example, improve sealing of the native leaflet and thusprevent or further reduce mitral regurgitation.

Referring to FIG. 30, the prosthetic spacer device 500 can also includea cover 540. In some embodiments, the cover 540 can be disposed on thecoaption member 510, the paddles 520, 522, and/or the paddle frames 524.The cover 540 can be configured to prevent or reduce blood-flow throughthe prosthetic spacer device 500 and/or to promote native tissueingrowth. In some embodiments, the cover 540 can be a cloth or fabricsuch as PET, velour, or other suitable fabric. In other embodiments, inlieu of or in addition to a fabric, the cover 540 can include a coating(e.g., polymeric) that is applied to the prosthetic spacer device 500.

FIGS. 31-32 illustrate the implantable prosthetic device 500 of FIGS. 28and 29 with anchors 508 of an anchor portion 506 and clasps 530 in openpositions. The device 500 is deployed from a delivery sheath (not shown)and includes a coaption portion 504 and the anchor portion 506. Thedevice 500 is loaded in the delivery sheath in the fully extended orbailout position, because the fully extended or bailout position takesup the least space and allows the smallest catheter to be used (See FIG.35). Or, the fully extended position allows the largest device 500 to beused for a given catheter size. The coaption portion 504 of the deviceincludes a coaption element 510 for implantation between the leaflets ofthe native mitral valve. An insert 516A is disposed inside the coaptionelement 510. The insert 516A and the coaption element 510 are slidablyattached to an actuation wire or shaft 512. The anchors 508 of thedevice 500 include outer paddles 520 and inner paddles 522 that areflexibly connected to the cap 514 and the coaption element 510.Actuation of the actuation wire or shaft 512 opens and closes theanchors 508 of the device 500 to grasp the mitral valve leaflets duringimplantation.

The actuation wire 512 extends through the delivery sheath (not shown),the proximal collar 511, the coaption element 510, the insert 516A, andextends to the cap 514. Extending and retracting the actuation wire 512increases and decreases the spacing between the coaption element 510 andthe cap 514, respectively. This changing of the spacing between thecoaption element 510 and the cap 514 causes the anchor portion 506 ofthe device to move between different positions.

The proximal collar 511 optionally includes a collar seal 513 that formsa seal around the actuation wire or shaft 512 during implantation of thedevice 500, and that seals shut when the actuation wire 512 is removedto substantially close the proximal end of the device 500 to blood flowthrough the interior of the coaption element 510 after implantation. Insome embodiments, a coupler or means for coupling 2214 (see FIG. 145)removably engages and attaches the proximal collar 511 and the coaptionelement 500 to the delivery sheath. In some embodiments, coupler ormeans for coupling 2214 is held closed around the proximal collar 511 bythe actuation wire 512, such that removal of the actuation wire 512allows fingers (see FIG. 145) of the coupler or means for coupling 2214to open, releasing the proximal collar 511.

The proximal collar 511 and the insert 516A in the coaption element 510slide along the actuation wire 512 during actuation to open and closethe paddles 520, 522 of the anchors 508. Referring to FIGS. 32A and 32B,in some embodiments the cap 514 optionally includes a sealing projection516 that sealingly fits within a sealing opening 517 of the insert 516A.In another exemplary embodiment, the cap 514 includes a sealing openingand the insert 516A includes a sealing projection. The insert 516A cansealingly fit inside a distal opening 515 of the coaption element 510,the coaption element 510 having a hollow interior. Referring to FIG.32A, the sealing projection 516 of the cap 514 sealingly engages theopening 517 in the insert 516A to maintain the distal end of thecoaption element 510 substantially closed to blood flow when the device500 is implanted and/or in the closed position.

In another exemplary embodiment, instead of the sealing engagementbetween the cap 514 and the insert 516A, the insert 516A can optionallyinclude a seal, like the collar seal 513 of the proximal collar, thatforms a seal around the actuation wire or shaft 512 during implantationof the device 500, and that seals shut when the actuation wire 512 isremoved. Such a seal can substantially close the distal end of thecoaption element 510 to blood flow after implantation.

The coaption element 510 and paddles 520, 522 are formed from a flexiblematerial that may be a metal fabric, such as a mesh, woven, braided, orformed in any other suitable way or a laser cut or otherwise cutflexible material. The material may be cloth, shape-memory alloywire—such as Nitinol—to provide shape-setting capability, or any otherflexible material suitable for implantation in the human body. Paddleframes 524 provide additional pinching force between the inner paddles522 and the coaption element 510 and assist in wrapping the leafletsaround the sides of the coaption element 510 for a better seal betweenthe coaption element 510 and the leaflets. In some embodiments, thecovering 540 illustrated by FIG. 30 extends around the paddle frames524.

The clasps 530 include a base or fixed arm 532, a moveable arm 534,barbs 536, and a joint portion 538. The fixed arms 532 are attached tothe inner paddles 522, with the joint portion 538 disposed proximate thecoaption element 510. The barbed clasps have flat surfaces and do notfit in a recess of the paddle. Rather, the flat portion of the barbedclasps are disposed against the surface of the inner paddle 522. Forexample, the fixed arms 532 are attached to the inner paddles 522through holes or slots 533 with sutures (not shown). The fixed arms 532may be attached to the inner paddles 522 with any suitable means, suchas screws or other fasteners, crimped sleeves, mechanical latches orsnaps, welding, adhesive, or the like. The fixed arms 532 remainsubstantially stationary relative to the inner paddles 522 when themoveable arms 534 are opened to open the barbed clasps 530 and exposethe barbs 536. The barbed clasps 530 are opened by applying tension toactuation lines (not shown) attached to holes 535 in the moveable arms534, thereby causing the moveable arms 534 to pivot or flex on the jointportions 538.

During implantation, the anchors 508 are opened and closed to grasp thenative mitral valve leaflets between the paddles 520, 522 and thecoaption element 510. The barbed clasps 530 further secure the nativeleaflets by engaging the leaflets with barbs 536 and pinching theleaflets between the moveable and fixed arms 534, 532. The barbs 536 ofthe barbed clasps 530 increase friction with the leaflets or maypartially or completely puncture the leaflets. The actuation lines canbe actuated separately so that each barbed clasp 530 can be opened andclosed separately. Separate operation allows one leaflet to be graspedat a time, or for the repositioning of a clasp 530 on a leaflet that wasinsufficiently grasped, without altering a successful grasp on the otherleaflet. The barbed clasps 530 can open and close when the inner paddle522 is not closed, thereby allowing leaflets to be grasped in a varietyof positions as the particular situation requires.

Referring now to FIG. 33, an exemplary barbed clasp 600 for use inimplantable prosthetic devices, such as the devices described above, isshown. However, a wide variety of different barbed clasps can be used.Examples of barbed clasps that can be used include, but are not limitedto any of the barbed clasps disclosed in the present application and anyof the applications that are incorporated herein by reference and/orthat the present application claims priority to. In the illustratedexample, the barbed clasp 600 is formed from a top layer 602 and abottom layer 604. The two-layer design of the clasp 600 allow thinnersheets of material to be used, thereby improving the flexibility of theclasp 600 over a clasp formed from a single thicker sheet, whilemaintaining the strength of the clasp 600 needed to successfully retaina native valve leaflet.

The barbed clasp 600 includes a fixed arm 610, a jointed portion 620,and a movable arm 630 having a barbed portion 640. The top and bottomlayers 602, 604 have a similar shape and in certain embodiments areattached to each other at the barbed portion 640. However, the top andbottom layers 602, 604 can be attached to one another at other oradditional locations. The jointed portion 620 is spring-loaded so thatthe fixed and moveable arms 610, 630 are biased toward each other whenthe barbed clasp 600 is in a closed condition. When assembled to animplantable prosthetic device, the fixed arm 610 is attached to aportion of the prosthetic device. The clasp 600 is opened by pulling onan actuation line attached to the moveable arm 630 until the springforce of the joint portion 620 is overcome.

The fixed arm 610 is formed from a tongue 611 of material extending fromthe jointed portion 620 between two side beams 631 of the moveable arm630. The tongue 611 is biased between the side beams 631 by the jointportion 620 such that force must be applied to move the tongue 611 froma neutral position located beyond the side beams 631 to a preloadedposition substantially parallel with the side beams 631. The tongue 611is held in the preloaded position by an optional T-shaped cross-bar 614that is attached to the tongue 611 and extends outward to engage theside beams 631. In another exemplary embodiment, the cross-bar isomitted and the tongue 611 is attached to the inner paddle 522, and theinner paddle 522 maintains the clasp in the preloaded position. In thetwo-layer clasp application, the top and bottom layers 602, 604 or justthe top layer can be attached to the inner paddle. In some embodiments,the angle between the fixed and moveable arms 610, 630 when the tongueis in the neutral position is about 30 to about 100 degrees, 30 to about90 degrees, or about 30 to about 60 degrees, or about 40 to about 50degrees, or about 45 degrees.

The tongue 611 includes holes 612 for receiving sutures (not shown) thatattach the fixed arm 610 to an implantable device. The fixed arm 610 maybe attached to an implantable device, such as with screws or otherfasteners, crimped sleeves, mechanical latches or snaps, welding,adhesive, or the like. In certain embodiments, the holes 612 areelongated slots or oval-shaped holes to accommodate sliding of thelayers 602, 604 without damaging the sutures attaching the clasp 600 toan implantable device.

The joint portion 620 is formed by two beam loops 622 that extend fromthe tongue 611 of the fixed arm 610 to the side beams 631 of themoveable arm 630. In certain embodiments, the beam loops 622 arenarrower than the tongue 611 and side beam 631 to provide additionalflexibility. The beam loops 622 each include a center portion 624extending from the tongue 611 and an outer portion 626 extending to theside beams 631. The beam loops 622 are bent into a somewhat spiral orhelical shape by bending the center and outer portions 624, 626 inopposite directions, thereby forming an offset or step distance 628between the tongue 611 and side beams 631. The step distance 628provides space between the arms 610, 630 to accommodate the nativeleaflet of the mitral valve after it is grasped. In certain embodiments,the step distance 628 is about 0.5 millimeter to about 1 millimeters, orabout 0.75 millimeters.

When viewed in a top plan view, the beam loops have an “omega-like”shape. This shape of the beam loops 622 allows the fixed and moveablearms 610, 630 to move considerably relative to each other withoutplastically deforming the clasp material. For example, in certainembodiments, the tongue 611 can be pivoted from a neutral position thatis approximately 45 degrees beyond the moveable arm 630 to a fully openposition that ranges from about 140 degrees to about 200 degrees, toabout 170 degrees to about 190 degrees, or about 180 degrees from themoveable arm 630 without plastically deforming the clasp material. Incertain embodiments, the clasp material plastically deforms duringopening without reducing or without substantially reducing the pinchforce exerted between the fixed and moveable arms in the closedposition.

Preloading the tongue 611 enables the clasp 600 to maintain a pinchingor clipping force on the native leaflet when closed. The preloading ofthe tongue 611 provides a significant advantage over prior art clipsthat provide little or no pinching force when closed. Additionally,closing the clasp 600 with spring force is a significant improvementover clips that use a one-time locking closure mechanism, as the clasp600 can be repeatedly opened and closed for repositioning on the leafletwhile still maintaining sufficient pinching force when closed. Inaddition, the spring-loaded clasps also allow for easier removal of thedevice over time as compared to a device that locks in a closed position(after tissue ingrowth). In one exemplary embodiment, both the claspsand the paddles are spring biased to their closed positions (as opposedto being locked in the closed position), which can allow for easierremoval of the device after tissue ingrowth.

The barbed portion 640 of the moveable arm 630 includes an eyelet 642,barbs 644, and barb supports 646. Positioning the barbed portion of theclasp 600 toward an end of the moveable arm 630 increases the spacebetween the barbs 644 and the fixed arm 610 when the clasp 600 isopened, thereby improving the ability of the clasp 600 to successfullygrasp a leaflet during implantation. This distance also allows the barbs644 to more reliably disengage from the leaflet for repositioning. Incertain embodiments, the barbs of the clasps may be staggeredlongitudinally to further distribute pinch forces and local leafletstress.

The barbs 644 are laterally spaced apart at the same distance from thejoint portion 620, providing a superior distribution of pinching forceson the leaflet tissue while also making the clasp more robust to leafletgrasp than barbs arranged in a longitudinal row. In some embodiments,the barbs 644 can be staggered to further distribute pinch forces andlocal leaflet stress.

The barbs 644 are formed from the bottom layer 604 and the barb supports646 are formed from the top layer. In certain embodiments, the barbs areformed from the top layer 602 and the barb supports are formed from thebottom layer 604. Forming the barbs 644 only in one of the two layers602, 604 allows the barbs to be thinner and therefore effectivelysharper than a barb formed from the same material that is twice asthick. The barb supports 646 extend along a lower portion of the barbs644 to stiffen the barbs 644, further improving penetration andretention of the leaflet tissue. In certain embodiments, the ends of thebarbs 644 are further sharpened using any suitable sharpening means.

The barbs 644 are angled away from the moveable arm 630 such that theyeasily penetrate tissue of the native leaflets with minimal pinching orclipping force. The barbs 644 extend from the moveable arm at an angleof about 45 degrees to about 75 degrees, or about 45 degrees to about 60degrees, or about 48 to about 56 degrees, or about 52 degrees. The angleof the barbs 644 provides further benefits, in that force pulling theimplant off the native leaflet will encourage the barbs 644 to furtherengage the tissue, thereby ensuring better retention. Retention of theleaflet in the clasp 600 can be further improved by the position of theT-shaped cross bar 614 near the barbs 644 when the clasp 600 is closed.In this arrangement, the tissue pierced by the barbs 644 is pinchedagainst the moveable arm 630 at the cross bar 614 location, therebyforming the tissue into an S-shaped torturous path as it passes over thebarbs 644. Thus, forces pulling the leaflet away from the clasp 600 willencourage the tissue to further engage the barbs 644 before the leafletscan escape. For example, leaflet tension during diastole can encouragethe barbs to pull toward the end portion of the leaflet. The S-shapedpath can utilize the leaflet tension during diastole to more tightlyengage the leaflets with the barbs.

Each layer 602, 604 of the clasp 600 is laser cut from a sheet ofshape-memory alloy, such as Nitinol. The top layer 602 is aligned andattached to the bottom layer 604. In certain embodiments, the layers602, 604 are attached at the barbed portion 640 of the moveable arm 630.For example, the layers 602, 604 may be attached only at the barbedportion 640, to allow the remainder of the layers to slide relative toone another. Portions of the combined layers 602, 604, such as a fixedarm 610, barbs 644 and barb supports 646, and beam loops 622 are bentinto a desired position. The layers 602, 604 may be bent and shape-settogether or may be bent and shape-set separately and then joinedtogether. The clasp 600 is then subjected to a shape-setting process sothat internal forces of the material will tend to return to the setshape after being subjected to deformation by external forces. Aftershape-setting, the tongue 611 is moved to its preloaded position so thatthe cross-bar 614 can be attached. In one exemplary embodiment, theclasp 600 can optionally be completely flattened for delivery through adelivery sheath and allowed to expand once deployed within the heart.The clasp 600 is opened and closed by applying and releasing tension onan actuation line, suture, wire, rod, catheter, or the like (not shown)attached to the moveable arm 630. The suture is inserted through aneyelet 642 near the barbed portion 640 of the moveable arm 630 and wrapsaround the moveable arm 630 before returning to the delivery sheath. Incertain embodiments, an intermediate suture loop is made through theeyelet and the suture is inserted through the intermediate loop. Analternate embodiment of the intermediate loop can be composed of fabricor another material attached to the movable arm, instead of a sutureloop.

An intermediate loop of suture material reduces friction experienced bythe actuation suture relative to the friction between the actuationsuture and the clasp material. When the suture is looped through theeyelet 642 or intermediate loop, both ends of the actuation sutureextend back into and through a delivery sheath (e.g., FIG. 8). Thesuture can be removed by pulling one end of the suture proximally untilthe other end of the suture pulls through the eyelet or intermediateloop and back into the delivery sheath.

Referring now to FIG. 34, a close-up view of one of the leaflets 20, 22grasped by a barbed clasp such as clasps 430, 530 is shown. The leaflet20, 22 is grasped between the moveable and fixed arms 434, 534 of theclasp 430, 530. As shown in FIG. 34, the tissue of the leaflet 20, 22 isnot pierced by the barbs 436, 536, though in some embodiments the barbs436, 536 may partially or fully pierce through the leaflet 20, 22. Theangle and height of the barbs 436, 536 relative to the moveable arm 434,534 helps to secure the leaflet 20, 22 within the clasp 430, 530. Inparticular, a force pulling the implant off of the native leaflet willencourage the barbs 436, 536 to further engage the tissue, therebyensuring better retention. Retention of the leaflet 20, 22 in the clasp430, 530 is further improved by the position of fixed arm 432, 532 nearthe barbs 436, 536 when the clasp 430, 530 is closed. In thisarrangement, the tissue is formed by the fixed arms 432, 532 and themoveable arms 434, 534 and the barbs 436, 536 into an S-shaped torturouspath. Thus, forces pulling the leaflet away from the clasp 430, 530 willencourage the tissue to further engage the barbs 436, 536 before theleaflets can escape. For example, as mentioned above, leaflet tensionduring diastole can encourage the barbs to pull toward the end portionof the leaflet. The S-shaped path can utilize the leaflet tension duringdiastole to more tightly engage the leaflets with the barbs.

Referring now to FIGS. 35-46, the implantable device 500 is shown beingdelivered and implanted within the native mitral valve MV of the heartH. As described above, the device 500 has a covering 540 (see FIG. 30)over the coaption element 510, clasps 530, inner paddles 522 and/or theouter paddles 520. The device 500 is deployed from a delivery sheath 502and includes a coaption portion 504 and an anchor portion 506 includinga plurality of anchors 508 (i.e., two in the illustrated embodiment).The coaption portion 504 of the device includes a coaption element 510for implantation between the leaflets 20, 22 of the native mitral valveMV that is slidably attached to an actuation wire or shaft 512.Actuation of the actuation wire or shaft 512 opens and closes theanchors 508 of the device 500 to grasp the mitral valve leaflets 20, 22during implantation.

The anchors 508 of the device 500 include outer paddles 520 and innerpaddles 522 that are flexibly connected to the cap 514 and the coaptionelement 510. The actuation wire 512 extends through a capture mechanism503 (see FIG. 41), delivery sheath 502, and the coaption element 510 tothe cap 514 connected to the anchor portion 506. Extending andretracting the actuation wire 512 increases and decreases the spacingbetween the coaption element 510 and the cap 514, respectively. In theexample illustrated by FIGS. 35-46, the pair of inner and outer paddles522, 520 are moved in unison, rather than independently, by a singleactuation wire 512. Also, the positions of the clasps 530 are dependenton the positions of the paddles 522, 520. For example, referring to FIG.45 closing the paddles 522, 520 also closes the clasps. In one exemplaryembodiment, the device 500 can be made to have the paddles 520, 522 beindependently controllable in the same manner as the FIG. 11Aembodiment.

Fingers of the capture mechanism 503 removably attach the collar 511 tothe delivery sheath 502. The collar 511 and the coaption element 510slide along the actuation wire 512 during actuation to open and closethe anchors 508 of the anchor portion 506. In some embodiments, thecapture mechanism 503 is held closed around the collar 511 by theactuation wire 512, such that removal of the actuation wire 512 allowsthe fingers of the capture mechanism 503 to open, releasing the collar511, and thus the coaption element 510.

The coaption element 510 and paddles 520, 522 can be formed from aflexible material that may be a metal fabric, such as a mesh, woven,braided, or formed in any other suitable way or a laser cut or otherwisecut flexible material. The flexible material may be cloth, shape-memoryalloy wire—such as Nitinol—to provide shape-setting capability, or anyother flexible material suitable for implantation in the human body.

The barbed clasps 530 include a base or fixed arm 532, a moveable arm534, barbs 536 (see FIG. 41), and a joint portion 538. The fixed arms532 are attached to the inner paddles 522, with the joint portions 538disposed proximate the coaption element 510. Sutures (not shown) attachthe fixed arms 532 to the inner paddles 522. The fixed arms 532 may beattached to the inner paddles 522 with any suitable means, such asscrews or other fasteners, crimped sleeves, mechanical latches or snaps,welding, adhesive, or the like. The fixed arms 532 remain substantiallystationary when the moveable arms 534 are opened to open the barbedclasps 530 and expose the barbs 536. The barbed clasps 530 are opened byapplying tension to actuation lines 537 attached to the moveable arms534, thereby causing the moveable arms 534 to pivot or flex on the jointportions 538.

During implantation, the anchors 508 are opened and closed to grasp thenative mitral valve leaflets between the paddles 520, 522 and thecoaption element 510. The outer paddles 520 have a wide curved shapethat fits around the curved shape of the coaption element 510 to moresecurely grip the leaflets 20, 22. The curved shape and rounded edges ofthe outer paddle 520 also prohibits tearing of the leaflet tissue. Thebarbed clasps 530 further secure the native leaflets by engaging theleaflets with barbs 536 and pinching the leaflets between the moveableand fixed arms 534, 532. The barbs 536 of the barbed clasps 530 increasefriction with the leaflets or may partially or completely puncture theleaflets. The actuation lines can be actuated separately so that eachbarbed clasp 530 can be opened and closed separately. Separate operationallows one leaflet to be grasped at a time, or for the repositioning ofa clasp 530 on a leaflet that was insufficiently grasped, withoutaltering a successful grasp on the other leaflet. The barbed clasps 530can be fully opened and closed when the inner paddle 522 is not closed,thereby allowing leaflets to be grasped in a variety of positions as theparticular situation requires.

The device 500 is loaded in the delivery sheath in the fully openposition, because the fully open position takes up the least space andallows the smallest catheter to be used (or the largest device 500 to beused for a given catheter size). Referring now to FIG. 35, the deliverysheath is inserted into the left atrium LA through the septum and thedevice 500 is deployed from the delivery sheath 502 in the fully opencondition. The actuation wire 512 is then retracted to move the device500 into the fully closed condition shown in FIGS. 36-37 and thenmaneuvered towards the mitral valve MV as shown in FIG. 38. Referringnow to FIG. 39, when the device 500 is aligned with the mitral valve MV,the actuation wire 512 is extended to open the paddles 520, 522 into thepartially opened position and the actuation lines 537 are retracted toopen the barbed clasps 530 to prepare for leaflet grasp. Next, as shownin FIGS. 40-41, the partially open device 500 is inserted through themitral valve MV until leaflets 20, 22 are properly positioned in betweenthe inner paddles 522 and the coaption element 510 and inside the openbarbed clasps 530. FIG. 42 shows the device 500 with both clasps 530closed, though the barbs 536 of one clasp 530 missed one of the leaflets22. As can be seen in FIGS. 42-44, the out of position clasp 530 isopened and closed again to properly grasp the missed leaflet 22. Whenboth leaflets 20, 22 are grasped properly, the actuation wire 512 isretracted to move the device 500 into the fully closed position shown inFIG. 45. With the device 500 fully implanted in the native mitral valveMV, the actuation wire 512 is withdrawn to release the capture mechanism503 from the proximal collar 511. Once deployed, the device 500 may bemaintained in the fully closed position with a mechanical means such asa latch or may be biased to remain closed through the use of springmaterial, such as steel, and/or shape-memory alloys such as Nitinol. Forexample, the paddles 520, 522 may be formed of steel or Nitinolshape-memory alloy—produced in a wire, sheet, tubing, or laser sinteredpowder—and are biased to hold the outer paddles 520 closed around theinner paddles 522, coaption element 510, and the barbed clasps 530pinched around native leaflets 20, 22.

The device 500 can have a wide variety of different shapes and sizes.Referring to FIGS. 6 and 6A-6E, in an exemplary embodiment, the coaptionelement 510 functions as a gap filler in the valve regurgitant orifice,such as the gap 26 in the mitral valve MV illustrated by FIG. 6.Referring to FIG. 6A, since the coaption element 510 is deployed betweentwo opposing valve leaflets 20, 22, the leaflets will not coapt againsteach other in the area of the coaption element 510, but coapt againstthe coaption element 510 instead. This reduces the distance the leaflets20, 22 need to be approximated. A reduction in leaflet approximationdistance can result in several advantages. For example, the coaptionelement and resulting reduced approximation can facilitate repair ofsevere mitral valve anatomies, such as large gaps in functional valvedisease (See for example, FIG. 6). Since the coaption element 510reduces the distance the native valves have to be approximated, thestress in the native valves can be reduced or minimized Shorterapproximation distance of the valve leaflets 20, 22 can require lessapproximation forces which can result in less tension of the leafletsand less diameter reduction of the valve annulus. The smaller reductionof the valve annulus (or no reduction of the valve annulus) can resultin less reduction in valve orifice area as compared to a device withouta spacer. As a result, the coaption element 510 can reduce thetransvalvular gradients.

In one exemplary embodiments, the paddle frames 524 conform to the shapeof the coaption element 510. In one example, if the coaption element 510is wider than the paddle frames 524, a distance (gap) between theopposing leaflets 20, 22 can be created by the device 500. Referring toFIGS. 6A-6E, in one exemplary embodiment the paddles are configured toconform to the shape or geometry of the coaption element 510. As aresult, the paddles can mate with both the coaption element 510 and thenative valve. Referring to FIGS. 6D and 6E, in one exemplary embodimentthe paddles 524 surround the coaption element 510. Thus, when theleaflets 20, 22 are coapted against the coaption element 510, theleaflets 20, 2 fully surround or “hug” the coaption element 510 in itsentirety, thus small leaks on the medial and lateral aspects of thecoaption element 510 an be prevented. FIGS. 6B and 6C illustrate thevalve repair device 500 attached to mitral valve leaflets 20, 22 fromthe ventricular side of the mitral valve. FIG. 6A illustrates the valverepair device 500 attached to mitral valve leaflets 20, 22 from theatrial side of the mitral valve. Referring to FIGS. 6A and 6B, when thepaddles have a geometry that conforms to the geometry of the coaptionelement 510, the leaflets 20, 22 can coapt around the coaption elementand/or along the length of the spacer. Referring to FIG. 6E, a schematicatrial view/surgeons view depicts the paddle frames (which would notactually be visible from a true atrial view), conforming to the spacergeometry. The opposing leaflets 20, 22 (the ends of which would also notbe visible in the true atrial view) being approximated by the paddles,to fully surround or “hug” the coaption element 510.

Referring to FIGS. 6B-6E, because the paddle frames 524 conform to theshape of the coaption element 510, the valve leaflets 20, 22 can becoapted completely around the coaption element by the paddle frames 524,including on the lateral and medial aspects 601, 603 of the coaptionelement 510. This coaption of the leaflets 20, 22 against the lateraland medial aspects of the coaption element 510 would seem to contradictthe statement above that the presence of a coaption element 510minimizes the distance the leaflets need to be approximated. However,the distance the leaflets 20, 22 need to be approximated is stillminimized if the coaption element 510 is placed precisely at aregurgitant gap and the regurgitant gap is less than the width(medial-lateral) of the coaption element 510.

Referring to FIGS. 6A and 6E, the coaption element 510 can take a widevariety of different shapes. In one exemplary embodiment, when viewedfrom the top (and/or sectional views from the top; see FIGS. 95-102),the coaption element has an oval shape or an elliptical shape. The ovalor elliptical shape can allow the paddle frames 524 co conform to theshape of the coaption element and/or can reduce lateral leaks (See FIGS.65-83).

As mentioned above, the coaption element 510 can reduce tension of theopposing leaflets by reducing the distance the leaflets need to beapproximated to the coaption element 510 at the positions 601, 603. Thereduction of the distance of leaflet approximation at the positions 601,603 can result in the reduction of leaflet stresses and gradients. Inaddition, as is also explained above, the native valve leaflets 20, 22can surround or “hug” the coaption element in order to prevent lateralleaks. In one exemplary embodiment, the geometrical characteristics ofthe coaption element can be designed to preserve and augment these twocharacteristics of the device 500. Referring to FIG. 2A, as seen from aLeft Ventricular Outflow Tract (LVOT) view, the anatomy of the leaflets20, 22 is such that the inner sides of the leaflets coapt at the freeend portions and the leaflets 20, 22 start receding or spreading apartfrom each other. The leaflets 20, 22 spread apart in the atrialdirection, until each leaflet meets with the mitral annulus.

In one exemplary embodiment, the valve repair device 500 and itscoaption element 510 are designed to conform to the geometrical anatomyof the valve leaflets 20, 22. To achieve valve sealing, the valve repairdevice 500 can be designed to coapt the native leaflets to the coaptionelement, completely around the coaption element, including at the medial601 and lateral 603 positions of the coaption element 510. Additionally,a reduction on forces required to bring the leaflets into contact withthe coaption element 510 at the positions 601, 603 can minimize leafletstress and gradients. FIGS. 2B shows how a tapered or triangular shapeof a coaption element 510 will naturally adapt to the native valvegeometry and to its expanding leaflet nature (toward the annulus).

FIG. 6D illustrates the geometry of the coaption element 510 and thepaddle frame 524 from an LVOT perspective. As can be seen in this view,the coaption element 510 has a tapered shape being smaller in dimensionin the area closer to where the inside surfaces of the leaflets 20, 22are required to coapt and increase in dimension as the coaption elementextends toward the atrium. The depicted native valve geometry isaccommodated by a tapered coaption element geometry. Still referring toFIG. 6D, the tapered coaption element geometry, in conjunction with theillustrated expanding paddle frame 524 shape (toward the valve annulus)can help to achieve coaptation on the lower end of the leaflets, reducestress, and minimize transvalvular gradients.

Referring to FIG. 6C, in one exemplary embodiment remaining shapes ofthe coaption element 510 and the paddle frames 524 can be defined basedon an Intra-Commissural view of the native valve and the device 510. Twofactors of these shapes are leaflet coaptation against the coaptionelement 510 and reduction of stress on the leaflets due to the coaption.Referring to FIGS. 6C and 67, to both coapt the valve leaflets 20, 22against the coaption element 510 and reduce the stress applied to thevalve leaflets 20, 22 by the coaption element 510 and/or the paddles524, the coaption element 510 can have a round or rounded shape and thepaddle frame 524 can have a full radius that spans from one leg of thepaddles to the other leg of the paddles. The round shape of the coaptionelement and/or the illustrated fully rounded shape of the paddle framewill distribute the stresses on the leaflets 20, 22 across a large,curved engagement area 607. For example, in FIG. 6C, the force on theleaflets 20, 22 by the paddle frames is spread along the entire roundedlength of the paddle frame 524, as the leaflets 20 try to open duringthe diastole cycle.

Referring to FIG. 67, in one exemplary embodiment, to cooperate with thefull rounded shape of the paddle frames 524, and/or in order to maximizeleaflet coaptation against the coaption element 510 andleaflet-to-leaflet coaptation at the sides 601, 603 of the coaptionelement 510, the shape of the coaption element in the intra-commissuralview follows a round shape. Referring to FIG. 67, the round shape of thecoaption element in this view substantially follows or is close to theshape of the paddle frames 524.

In one exemplary embodiment, the overall shape of the coaption element510 is an elliptical or oval cross section when seen from the surgeon'sview (top view—See FIG. 70), a tapered shape or cross section when seenfrom an LVOT view (side view—See FIG. 69), and a substantially roundshape or rounded shape when seen from an intra-commissural view (SeeFIG. 68). In one exemplary embodiment, a blend of these three geometriescan result in the three-dimensional shape of the illustrated coaptionelement 510 that achieves the benefits described above.

In one exemplary embodiment, the dimensions of the coaption element areselected to minimize the number of implants that a single patient willrequire (preferably one), while at the same time maintaining lowtransvalvular gradients. In one exemplary embodiment, theanterior-posterior distance X_(47B) at the top of the spacer is about 5mm, and the medial-lateral distance X_(67D) of the spacer at its widestis about 10 mm. In one exemplary embodiment, the overall geometry of thedevice 510 can be based on these two dimensions and the overall shapestrategy described above. It should be readily apparent that the use ofother anterior-posterior distance anterior-posterior distance X_(47B)and medial-lateral distance X_(67D) as starting points for the devicewill result in a device having different dimensions. Further, usingother dimensions and the shape strategy described above will also resultin a device having different dimensions.

Tables A, B, and C provide examples of values and ranges for dimensionsof the device and components of the device for some exemplaryembodiments. However, the device can have a wide variety of differentshapes and sizes and need not have all or any of the dimensional valuesor dimensional ranges provided in Tables A, B, and C. Table A providesexamples of linear dimensions X in millimeters and ranges of lineardimensions in millimeters for the device and components of the device.Table B provides examples of radius dimensions R in millimeters andranges of radius dimensions in millimeters for the device and componentsof the device. Table C provides examples of angular dimensions a indegrees and ranges of angular dimensions in degrees for the device andcomponents of the device. The subscripts for each of the dimensionsindicates the drawing in which the dimension first appears.

TABLE A Linear Dimensions (mm) Range A Range B Range C Range C Example(max) (min) (max) (min) (max) (min) (max) (min) X_(47A) 2.8 1.4 4.2 2.13.5 2.52 3.08 2.66 2.94 X_(47B) 5.3 2.65 7.95 3.975 6.625 4.77 5.835.035 5.565 X_(47C) 2.8 1.4 4.2 2.1 3.5 2.52 3.08 2.66 2.94 X_(47D) 3.31.65 4.95 2.475 4.125 2.97 3.63 3.135 3.465 X_(47E) 5.4 2.7 8.1 4.056.75 4.86 5.94 5.13 5.67 X_(47F) 8 4 12 6 10 7.2 8.8 7.6 8.4 X_(47G) 10.5 1.5 0.75 1.25 0.9 1.1 0.95 1.05 X_(52A) 12 6 18 9 15 10.8 13.2 11.412.6 X_(58A) 11 5.5 16.5 8.25 13.75 9.9 12.1 10.45 11.55 X_(59A) 27 13.540.5 20.25 33.75 24.3 29.7 25.65 28.35 X_(59B) 8 4 12 6 10 7.2 8.8 7.68.4 X_(59C) 7 3.5 10.5 5.25 8.75 6.3 7.7 6.65 7.35 X_(67A) 2.4 1.2 3.61.8 3 2.16 2.64 2.28 2.52 X_(67B) 3.7 1.85 5.55 2.775 4.625 3.33 4.073.515 3.885 X_(67C) 10 5 15 7.5 12.5 9 11 9.5 10.5 X_(67D) 10 5 15 7.512.5 9 11 9.5 10.5 X_(67E) 15 7.5 22.5 11.25 18.75 13.5 16.5 14.25 15.75X_(67F) 1 0.5 1.5 0.75 1.25 0.9 1.1 0.95 1.05 X₆₈ 14.2 7.1 21.3 10.6517.75 12.78 15.62 13.49 14.91 X_(70A) 1.7 0.85 2.55 1.275 2.125 1.531.87 1.615 1.785 X_(70B) 2.8 1.4 4.2 2.1 3.5 2.52 3.08 2.66 2.94 X_(71A)6.2 3.1 9.3 4.65 7.75 5.58 6.82 5.89 6.51 X_(71B) 5.4 2.7 8.1 4.05 6.754.86 5.94 5.13 5.67 X_(71C) 0.9 0.45 1.35 0.675 1.125 0.81 0.99 0.8550.945 X_(71D) 3.75 1.875 5.625 2.8125 4.6875 3.375 4.125 3.5625 3.9375X_(71E) 4.5 2.25 6.75 3.375 5.625 4.05 4.95 4.275 4.725 X_(72A) 10.4 5.215.6 7.8 13 9.36 11.44 9.88 10.92 X_(91A) 8.8 4.4 13.2 6.6 11 7.92 9.688.36 9.24 X_(91B) 7.8 3.9 11.7 5.85 9.75 7.02 8.58 7.41 8.19 X_(91C) 8.14.05 12.15 6.075 10.125 7.29 8.91 7.695 8.505 X_(91D) 13.6 6.8 20.4 10.217 12.24 14.96 12.92 14.28 X_(92A) 0.05 0.025 0.075 0.0375 0.0625 0.0450.055 0.0475 0.0525 X_(92B) 1.5 0.75 2.25 1.125 1.875 1.35 1.65 1.4251.575 X_(92C) 10.8 5.4 16.2 8.1 13.5 9.72 11.88 10.26 11.34 X_(95A) 13.86.9 20.7 10.35 17.25 12.42 15.18 13.11 14.49 X_(96A) 8.2 4.1 12.3 6.1510.25 7.38 9.02 7.79 8.61 X_(96B) 5.1 2.55 7.65 3.825 6.375 4.59 5.614.845 5.355 X_(96C) 0.5 0.25 0.75 0.375 0.625 0.45 0.55 0.475 0.525 X₉₇10.8 5.4 16.2 8.1 13.5 9.72 11.88 10.26 11.34 X_(98A) 9.8 4.9 14.7 7.3512.25 8.82 10.78 9.31 10.29 X_(98B) 5 2.5 7.5 3.75 6.25 4.5 5.5 4.755.25 X₉₉ 8 4 12 6 10 7.2 8.8 7.6 8.4 X_(100A) 9.7 4.85 14.55 7.27512.125 8.73 10.67 9.215 10.185 X_(100B) 4 2 6 3 5 3.6 4.4 3.8 4.2 X₁₀₁5.2 2.6 7.8 3.9 6.5 4.68 5.72 4.94 5.46 X_(102A) 8 4 12 6 10 7.2 8.8 7.68.4 X_(102B) 2.9 1.45 4.35 2.175 3.625 2.61 3.19 2.755 3.045 X_(117A)4.2 2.1 6.3 3.15 5.25 3.78 4.62 3.99 4.41 X_(117B) 14.5 7.25 21.7510.875 18.125 13.05 15.95 13.775 15.225 X_(117C) 13 6.5 19.5 9.75 16.2511.7 14.3 12.35 13.65

TABLE B Radius Dimensions (mm) Range A Range B Range C Range C Example(max) (min) (max) (min) (max) (min) (max) (min) R_(47A) 1.3 0.65 1.950.975 1.625 1.17 1.43 1.235 1.365 R_(47B) 1 0.5 1.5 0.75 1.25 0.9 1.10.95 1.05 R_(47C) 0.6 0.3 0.9 0.45 0.75 0.54 0.66 0.57 0.63 R_(47D) 52.5 7.5 3.75 6.25 4.5 5.5 4.75 5.25 R_(47E) 0.75 0.375 1.125 0.56250.9375 0.675 0.825 0.7125 0.7875 R_(67A) 0.75 0.375 1.125 0.5625 0.93750.675 0.825 0.7125 0.7875 R_(67B) 0.9 0.45 1.35 0.675 1.125 0.81 0.990.855 0.945 R_(70A) 1.4 0.7 2.1 1.05 1.75 1.26 1.54 1.33 1.47 R_(70B)0.4 0.2 0.6 0.3 0.5 0.36 0.44 0.38 0.42 R_(70C) 0.6 0.3 0.9 0.45 0.750.54 0.66 0.57 0.63 R_(70D) 7 3.5 10.5 5.25 8.75 6.3 7.7 6.65 7.35R_(71A) 1.6 0.8 2.4 1.2 2 1.44 1.76 1.52 1.68 R_(72A) 1.85 0.925 2.7751.3875 2.3125 1.665 2.035 1.7575 1.9425 R_(73A) 1.9 0.95 2.85 1.4252.375 1.71 2.09 1.805 1.995 R_(91A) 9.2 4.6 13.8 6.9 11.5 8.28 10.128.74 9.66 R_(91B) 0.3 0.15 0.45 0.225 0.375 0.27 0.33 0.285 0.315R_(91C) 0.3 0.15 0.45 0.225 0.375 0.27 0.33 0.285 0.315 R_(92A) 0.750.375 1.125 0.5625 0.9375 0.675 0.825 0.7125 0.7875 R_(94A) 1.65 0.8252.475 1.2375 2.0625 1.485 1.815 1.5675 1.7325 R_(96A) 1.7 0.85 2.551.275 2.125 1.53 1.87 1.615 1.785 R_(96B) 4.7 2.35 7.05 3.525 5.875 4.235.17 4.465 4.935 R_(98A) 1.3 0.65 1.95 0.975 1.625 1.17 1.43 1.235 1.365R_(98B) 7.6 3.8 11.4 5.7 9.5 6.84 8.36 7.22 7.98 R_(100A) 0.9 0.45 1.350.675 1.125 0.81 0.99 0.855 0.945 R_(100B) 9.6 4.8 14.4 7.2 12 8.6410.56 9.12 10.08 R_(102A) 0.45 0.225 0.675 0.3375 0.5625 0.405 0.4950.4275 0.4725 R_(102B) 8.5 4.25 12.75 6.375 10.625 7.65 9.35 8.075 8.925R_(115A) 9.3 4.65 13.95 6.975 11.625 8.37 10.23 8.835 9.765 R_(115B) 7.83.9 11.7 5.85 9.75 7.02 8.58 7.41 8.19 R_(115C) 7.8 3.9 11.7 5.85 9.757.02 8.58 7.41 8.19 R_(115D) 6.7 3.35 10.05 5.025 8.375 6.03 7.37 6.3657.035 R_(115E) 1.5 0.75 2.25 1.125 1.875 1.35 1.65 1.425 1.575

TABLE C Angular Dimensions (degrees) Range A Range B Range C Range CExample (max) (min) (max) (min) (max) (min) (max) (min) α₄₇ 12 6 18 9 1510.8 13.2 11.4 12.6 α_(91A) 9 4.5 13.5 6.75 11.25 8.1 9.9 8.55 9.45α_(91B) 14 7 21 10.5 17.5 12.6 15.4 13.3 14.7 α_(91C) 20 10 30 15 25 1822 19 21 α_(117A) 39 19.5 58.5 29.25 48.75 35.1 42.9 37.05 40.95α_(117B) 3 1.5 4.5 2.25 3.75 2.7 3.3 2.85 3.15

Referring now to FIGS. 47-61, an implantable device 500 is shown invarious positions and configurations. The implantable device 500 caninclude any other features for an implantable prosthetic devicediscussed in the present application, and the device 500 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The implantable device 500 has a proximal or attachment portion 505, acoaption element 510, inner anchor portions or inner paddles 522, outeranchor portions or outer paddles 520, anchor extension members or paddleframes 524, and a distal portion 507. The inner paddles 522 arejointably attached between the coaption element 510 and the outerpaddles 520. The outer paddles 520 are jointably attached between theinner paddles 522 and the distal portion 507. The paddle frames 524 areattached to the cap 514 at the distal portion 507 and extend to thejoint portion 523 between the inner and outer paddles 522, 520. In someembodiments, the paddle frames 524 are formed of a material that is morerigid and stiff than the material forming the paddles 522, 520 so thatthe paddle frames 524 provide support for the paddles 522, 520. In oneexemplary embodiment, the inner paddles 522 are stiff, relatively stiff,rigid, have rigid portions and/or are stiffened by a stiffening memberor the fixed portion of the clasps 530. The stiffening of the innerpaddle allows the device to move to the various different positionsshown and described herein. The inner paddle 522, the outer paddle 520,the coaption can all be interconnected as described herein, such thatthe device 500 is constrained to the movements and positions shown anddescribed herein.

Referring now to FIGS. 47-48, the device 500 is shown in a closedposition. When closed, the inner paddles 522 are disposed between theouter paddles 520 and the coaption element 510. In some embodiments, thedevice 500 includes clasps or gripping members 530 (FIG. 48) that can beopened and closed to grasp the native leaflets 20, 22 of the mitralvalve MV. The clasps 530 are attached to and move with the inner paddles522 and are disposed between the inner paddles 522 and the coaptionelement 510.

Referring now to FIGS. 49-51, the device 500 is shown in a partiallyopen position. The device 500 is moved into the partially open positionby an actuation wire or shaft 512 that passes through the attachmentportion 505 and coaption element 510 and can removably engage the distalportion 507. The actuation wire 512 is extended through the attachmentportion 505 such that a distance D between the attachment portion 505and distal portion 507 increases as the actuation wire 512 is extended.In the example illustrated by FIGS. 49-51, the pair of inner and outerpaddles 522, 520 are moved in unison, rather than independently, by asingle actuation wire 512. Also, the positions of the clasps 530 aredependent on the positions of the paddles 522, 520. For example,referring to FIG. 48 closing the paddles 522, 520 also closes theclasps. In one exemplary embodiment, the device 500 can be made to havethe paddles 520, 522 be independently controllable in the same manner asthe FIG. 11A embodiment.

Extending the actuation wire 512 pulls down on the bottom portions ofthe outer paddles 520 and paddle frames 524. The outer paddles 520 andpaddle frames 524 pull down on the inner paddles 522, where the innerpaddles 522 are connected to the outer paddles 520 and the paddle frames524. Because the attachment portion 505 and coaption element 510 areheld in place, the inner paddles 522 are caused to pivot or flex in anopening direction. The inner paddles 522, the outer paddles 520, and thepaddle frames all flex to the position shown in FIG. 49. Opening thepaddles 522, 520 and frames 524 forms a gap 520A between the coaptionelement 510 and the inner paddle 522 that can receive and grasp thenative leaflets 20.

As is described above, some embodiments of the device 500 include claspsor gripping members 530. When the device 500 is partially opened theclasps 530 are exposed. In some embodiments, the closed clasps 530 (FIG.50) can be opened (FIG. 51), thereby creating a second opening or gap530A for receiving and capturing the native leaflets 20, 22. The extentof the gap 530A in the clasps 530 is limited to the extent that theinner paddle 522 has spread away from the coaption element 510.

Referring now to FIGS. 52-54, the device 500 is shown in a laterallyextended or open position. The device 500 is moved into the laterallyextended or open position by continuing to extend the actuation wire 512described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the laterally extended or open position,the inner paddles 522 extend horizontally more than in other positionsof the device 500 and form an approximately 90-degree angle with thecoaption element 510. Similarly, the paddle frames 524 are at theirmaximum spread position when the device 500 is in the laterally extendedor open position. The increased gap 520A formed in the laterallyextended or open position allows clasps 530 to open further (FIG. 54)before engaging the coaption element 510, thereby increasing the size ofthe gap 530A.

Referring now to FIGS. 55-57, the device 500 is shown in athree-quarters extended position. The device 500 is moved into thethree-quarters extended position by continuing to extend the actuationwire 512 described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the three-quarters extended position, theinner paddles 522 are open beyond 90 degrees to an approximately135-degree angle with the coaption element 510. The paddle frames 524are less spread than in the laterally extended or open position andbegin to move inward toward the actuation wire 512 as the actuation wire512 extends further. The outer paddles 520 also flex back toward theactuation wire 512. As with the laterally extended or open position, theincreased gap 520A formed in the laterally extended or open positionallows clasps 530 to open even further (FIG. 57), thereby increasing thesize of the gap 530A.

Referring now to FIG. 58, the device 500 is shown in an almost fullyextended position. The device 500 is moved into the almost fullyextended position by continuing to extend the actuation wire 512described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the almost fully extended position theinner paddles 522 begin to approach an approximately 180-degree anglewith the coaption element 510. Although the inner paddles move to thisposition, the outer paddles 520 and the paddle frames 522 never move orflex to or past a ninety-degree angle with respect to the coaptionelement 510. In the almost fully extended position the inner and outerpaddles 522, 520 can have a somewhat curved shape.

Referring now to FIGS. 59-61, the device 500 is shown in a fullyextended position. The device 500 is moved into the fully extendedposition by continuing to extend the actuation wire 512 described above,thereby increasing the distance D between the attachment portion 505 anddistal portion 507 to a maximum distance allowable by the device 500.Continuing to extend the actuation wire 512 pulls down on the outerpaddles 520 and paddle frames 524, thereby causing the inner paddles 522to spread apart further from the coaption element 510. The outer paddles520 and paddle frames 524 move to a position where they are close to theactuation wire. In the fully extended position, the inner paddles 522are open to an approximately 180-degree angle with the coaption element510. The inner and outer paddles 522, 520 are stretched straight in thefully extended position to form an approximately 180-degree anglebetween the paddles 522, 520. The fully extended position of the device500 provides the maximum size of the gap 520A between the paddles, and,in some embodiments, allows clasps 530 to also open fully toapproximately 180 degrees (FIG. 61) between portions of the clasp 530.The position of the device 500 is the narrowest configuration. Thus, thefully extended position of the device 500 may be a desirable positionfor bailout of the device 500 from an attempted implantation or may be adesired position for placement of the device in a delivery catheter, orthe like. and 61A-61D, an implantable device 500A is shown in variouspositions and configurations. The implantable device 500A can includeany other features for an implantable prosthetic device discussed in thepresent application, and the device 500A can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

The implantable device 500A has a proximal or attachment portion 505A, acoaption element 510A, inner anchor portions or inner paddles 522A,outer anchor portions or outer paddles 520A, anchor extension members orpaddle frames 524A, and a distal portion 507A. The inner paddles 522Aare jointably attached between the coaption element 510A by jointportions 525A and the outer paddles 520A by joint portions 523A. Theouter paddles 520A are jointably attached between the inner paddles 522Aby joint portions 523A and the distal portion 507A by joint portions521A. The paddle frames 524A are attached to the cap 514A (FIG. 48A) atthe distal portion 507A and extend to the joint portion 523A between theinner and outer paddles 522A, 520A. In some embodiments, the paddleframes 524A are formed of a material that is more rigid and stiff thanthe material forming the paddles 522A, 520A so that the paddle frames524A provide support for the paddles 522A, 520A. The paddle frames 524Ainclude an opening or slot 524B for receiving the joint portions 523A(FIG. 65A). In some embodiments, the inner paddles 522A are stiff,relatively stiff, rigid, have rigid portions and/or are stiffened by astiffening member or the fixed portion of the clasps 530C. Thestiffening of the inner paddle allows the device to move to the variousdifferent positions shown and described herein. The inner paddle 522A,the outer paddle 520A, and the coaption element can all beinterconnected as described herein, such that the device 500A isconstrained to the movements and positions shown and described herein.

The coaption element 510A, inner paddles 522A, outer paddles 520A can beattached together by integrally forming the coaption element 510A andthe paddles 520A, 522A as a single, unitary component. This can beaccomplished, for example, by forming the coaption element 510A and thepaddles 520A, 522A from a continuous strip 501A of a braided or wovenmaterial, such as braided or woven nitinol wire.

The continuous strip 501A is attached a collar 511S i CAS FITMY4 97HTD,a cap 514A, paddle frames 524A, clasps 530C. In the illustratedembodiment, the coaption element 510A, hinge portions 521A, 523A, 525A,outer paddles 520A, and inner paddles 522A are formed from thecontinuous strip 501A. The continuous strip 501A may be a single layerof material or may include two or more layers. In certain embodiments,portions of the device 500A have a single layer of the strip of material501A and other portions are formed from multiple overlapping oroverlying layers of the strip of material 501A. For example, FIG. 47Ashows the coaption element 510A and inner paddles 522A formed frommultiple overlapping or overlying layers of the strip of material 501A.Consequently, the coaption element 510A and inner paddle 522A have anincreased stiffness relative to the outer paddles 520A that are formedfrom a single layer of material 501A. The single continuous strip ofmaterial 501A can start and end in various locations of the device 500A.The ends of the strip of material 501A can be in the same location ordifferent locations of the device 500A. For example, in the illustratedembodiment of FIG. 47A, the strip of material begins and ends in thelocation of the inner paddles 522.

The clasps 530C can comprise attachment or fixed portions 532C, arm ormoveable portions 534C, barbs 536C, and joint portions 538C. Theattachment or fixed portions 532C can be coupled to the inner paddles522A in various ways such as with sutures, adhesive, fasteners, welding,stitching, swaging, friction fit and/or other means for coupling withthe joint portions 538C disposed proximate the coaption element 510A.The clasps 530C can be similar to clasps 430.

The moveable portions 534C can pivot or flex relative to the fixedportions 532C between an open configuration (e.g., FIG. 54A) and aclosed configuration (FIGS. 48A). In some embodiments, the clasps 530Ccan be biased to the closed configuration. In the open configuration,the fixed portions 532C and the moveable portions 534C pivot or flexaway from each other such that native leaflets can be positioned betweenthe fixed portions 532C and the moveable portions 534C. In the closedconfiguration, the fixed portions 532C and the moveable portions 534Cpivot or flex toward each other, thereby clamping the native leafletsbetween the fixed portions 532C and the moveable portions 534C. Thefixed arms 532C remain substantially stationary when the moveable arms534C are opened to open the barbed clasps 530C and expose the barbs536C. The barbed clasps 530C are opened by applying tension to actuationlines 516A attached to the moveable arms 534C, thereby causing themoveable arms 534C to pivot or flex on the joint portions 538C.

Referring now to FIGS. 47A, and 48A-48H, the device 500A is shown in aclosed position. A side view of the device 500A is shown in FIGS. 48B,48C, and 48F, from a front view in Figures FIG. 48D, 48E, and 48G, andfrom a bottom view in FIG. 48H. The device 500A has a generally invertedtrapezoidal shape that is rounded and tapers toward the distal portion507A of the device 500A. From the front, the device 500A has a generallyrounded rectangle shape that tapers somewhat toward the distal portion507A. As can be seen from the bottom view of the device 500A shown inFIG. 48H, the device 500A has a generally rounded rectangle shape whenviewed from below (and when viewed from above as can be seen in, forexample, FIG. 70A).

In the closed configuration of the device 500A, the inner paddles 522Aare disposed between the outer paddles 520A and the coaption element510A. In some embodiments, the device 500A includes clasps or grippingmembers 530C (FIG. 48A) that can be opened and closed to grasp thenative leaflets 20, 22 of the mitral valve MV. The clasps 530C areattached to and move with the inner paddles 522A and are disposedbetween the inner paddles 522A and the coaption element 510A.

Referring now to FIGS. 48B-48D, the device 500A is shown attached to adelivery device 502A. The delivery device 502A has actuatable members orfingers 503A that releasably engage the attachment portion 505A. Anactuation wire 512A extends from the delivery device 502A to the cap514A through the attachment portion 505A and coaption element 510A ofthe prosthetic device 500A. Extending and retracting the actuation wire512A causes the device 500A to open and close, as it us described below.Actuation wires 516A extend from the delivery device 502A to attach tothe clasps 530C. Tension can be applied to the sutures 516A to open theclasps 530C and released to allow the clasps 530C to close. The device500A is shown separated from the delivery device 502A in a deployedcondition in FIGS. 48F-48G.

Referring now to FIGS. 48C and 48E, the device 500A is shown with acover 540A. The cover 540A can be formed from a single piece ofmaterial, or from multiple segments abutting or joined to each other. Inthe illustrated embodiment, the cover 540A has an outer or lower cover541A and an inner or upper cover 543A. The outer cover 541A covers thecap 514A, outer paddles 520A, inner paddles 522A, and clasps 530C. Theinner cover 543A covers the coaption element 510A and the proximal endsof the inner paddles 522A and clasps 530C where the coaption element510A meets the inner paddles 522A and clasps 530C. The cover 540A can bea cloth material such as polyethylene cloth of a fine mesh. The clothcover can provide a blood seal on the surface of the spacer, and/orpromote rapid tissue ingrowth.

Referring now to FIGS. 53A-53D and 54A-54D, the device 500A is shown ina laterally extended or open position. The device 500A is moved into theopen position by the actuation wire or shaft 512A that passes throughthe attachment portion 505A and coaption element 510A and can removablyengage the distal portion 507A. The actuation wire 512A is extendedthrough the attachment portion 505A such that distance D2 between theattachment portion 505A and distal portion 507A increases as theactuation wire 512A is extended. In the example illustrated by FIGS.53A-53D and 54A-54D, the pair of inner and outer paddles 520A, 522A aremoved in unison, rather than independently, by a single actuation wire512A. Also, the positions of the clasps 530C are dependent on thepositions of the paddles 520A, 522A. For example, referring to FIG. 48Aclosing the paddles 520A, 522A also closes the clasps 530C. In oneexemplary embodiment, the device 500A can be made to have the paddles520A, 522A be independently controllable in the same manner as the FIG.11A embodiment.

Extending the actuation wire 512A pulls down on the bottom portions ofthe outer paddles 520A and paddle frames 524A to transition the device500A from a closed to partially open position. The outer paddles 520Aand paddle frames 524A pull down on the inner paddles 522A where theinner paddles 522A are connected to the outer paddles 520A and thepaddle frames 524A. Because the attachment portion 505A and coaptionelement 510A are held in place, the inner paddles 522A are caused topivot or flex in an opening direction. The inner paddles 522A, the outerpaddles 520A, and the paddle frames all flex to the position shown inFIG. 53A. Opening the paddles 522A, 520A and frames 524 forms a gap 520Dbetween the coaption element 510A and the inner paddle 522A that canreceive and grasp the native leaflets 20.

Continuing to extend the actuation wire 512A pulls down on the outerpaddles 520A and paddle frames 524A, thereby causing the inner paddles522A to spread apart further from the coaption element 510A. In thelaterally extended or open position, the inner paddles 522A extendhorizontally more than in other positions of the device 500A and form anapproximately 90-degree angle with the coaption element 510A. Similarly,the paddle frames 524A are at their maximum spread position when thedevice 500A is in the laterally extended or open position. The increasedgap 520D formed in the laterally extended or open position allows clasps530C to open further (FIG. 54A) before engaging the coaption element510A, thereby increasing the size of the gap 530D as compared to thepartially open position.

As is described above, some embodiments of the device 500A includeclasps or gripping members 530A. When the device 500A is opened theclasps 530C are exposed. In some embodiments, the closed clasps 530C(FIGS. 53A-53D) can be opened (FIGS. 54A-54D), thereby creating a secondopening or gap 530D for receiving and capturing the native leaflets 20,22. The extent of the gap 530D in the clasps 530C is limited to theextent that the inner paddle 522A has spread away from the coaptionelement 510A.

Referring now to FIGS. 60A-60D and 61A-61D, the device 500A is shown ina fully extended position. The device 500A is moved into the fullyextended position by continuing to extend the actuation wire 512Adescribed above, thereby increasing the distance D2 between theattachment portion 505A and distal portion 507A to a maximum distanceallowable by the device 500A. Continuing to extend the actuation wire512A pulls down on the outer paddles 520A and paddle frames 524A,thereby causing the inner paddles 522A to extend further away from thecoaption element 510A. The outer paddles 520A and paddle frames 524Amove to a position where they are close to the actuation wire. In thefully extended position, the inner paddles 522A are open to anapproximately 180-degree angle with the coaption element 510A. The innerand outer paddles 522A, 520A are stretched substantially straight in thefully extended position to form an approximately 180-degree anglebetween the paddles 522A, 520A. The fully extended position of thedevice 500A provides the maximum size of the gap 520D between thepaddles, and, in some embodiments, allows clasps 530C to also open fullyto approximately 180 degrees (FIG. 61A) between portions of the clasp530A. The position of the device 500A is the narrowest configuration.Thus, the fully extended position of the device 500A may be a desirableposition for bailout of the device 500A from an attempted implantationor may be a desired position for placement of the device in a deliverycatheter, or the like.

Referring now to FIGS. 197-198, enlarged views of portions of FIG. 60Care shown. Referring now to FIG. 197, the inner cover 543A can be seencovering the coaption element 510A from the proximal portion 519B to thedistal portion 517A. The inner cover 543A is formed from a flat sheet(see FIG. 201) of a cloth material such as polyethylene cloth of a finemesh and is folded around the coaption element 510A and held in place bystitches 545A. Referring now to FIG. 198, the outer cover 541A can beseen covering the clasps 530C and inner paddles 522A. Collar portions548A of inner cover 543A cover the portion of the clasps 530C and innerpaddles 522A closest to the coaption element 510A. Transition portions547A of the inner cover 543A extend from the coaption element 510A tothe collar portions 548A to provide a smooth transition between thecoaption element 510A and the clasps 530C and inner paddles 522A so thatnative tissue is not caught on the device 500A during implantation.

Referring now to FIG. 199, an exploded view of the device 500A is shown.The coaption element 510A, outer paddles 520A, and inner paddles 522Aare formed from a single strip of material 501A, as described above. Thecollar 511D, cap 514A, paddle frames 524A, and clasps 530C are assembledto the strip of material 501A to form the device 500A. The cap 514Aincludes a retention body 560A with a locking aperture 561A forreceiving a retaining nut 562A having a threaded bore 564A that engagesa threaded portion 568A of a retaining bolt 566A. The threaded portion568A of the retaining bolt 566A is inserted through the opening 527B toengage the retention body and nut 560A, 562A to attach the cap 514A tothe strip of material 501A.

In some embodiments, a stiffening member 539C is attached to the innerpaddle 522A to stiffen the inner paddle 522A to maintain the innerpaddle in a straight or substantially straight configuration as theinner paddle is moved between the various positions. A cutout 539D inthe stiffening member 539C is shaped to receive the fixed arm 532C ofthe clasp 530C so that the stiffening member 539C can fit around thefixed arm 532C when both the stiffening member 539C and clasp 530C areattached to the inner paddle 522A. Like the fixed arm 532C, thestiffening member 539C may be coupled to the inner paddles 522A invarious ways such as with sutures, adhesive, fasteners, welding,stitching, swaging, friction fit and/or other means for coupling.

Referring now to FIG. 200, an enlarged view of the collar 511A attachedto the proximal portion 519B of the coaption element 510A is shown. Thecollar 511A includes protrusions 511B for releasably engaging thefingers 503A of the delivery device 502A. An aperture 515A in the collar511A receives the actuation wire 512A. The proximal portion 519B of thecoaption element 510A flares outward to form two loops 519D that areinserted through the arcuate openings 513A of the collar 511D to attachthe collar 511D to the proximal portion 519B of the coaption element510A. The loops 519D are formed by folding the strip of material 501A toform first and second layers 581A, 582A. In some embodiments, thearcuate openings 513A include an opening (not shown) similar to the

Referring now to FIGS. 201-202, enlarged and exploded views of the cap514A are shown, respectively. FIG. 201 shows an enlarged view of the cap514A attached to the distal portion 527A of the strip of material 501Ais shown. The retention body 560A, retaining nut 562A, and retainingbolt 566A cooperate to attach the paddle frames 524A to the distalportion 527A of the strip of material 501A. In particular, the retainingbolt 566A is inserted through the opening 527B of the distal portion527A (FIG. 202) to prohibit movement of the cap 514A along the strip ofmaterial 501A. A channel 560B in the retention body 560A and a flange567A of the bolt 566A form a passageway 514B through the cap 514A forthe distal portion 527A.

Referring now to FIG. 202, the components of the cap 514A are shown inan exploded view to better illustrate the features of the components ofthe cap 514A and paddle frames 524A and to show how those featuresinterlock during assembly of the cap 514A to the distal portion 527A.Forming the cap 514A from multiple components that can be assembledaround the strip of material 501A allows the cap 514A to be attachedafter the strip of material 501A has been folded to form the coaptionelement 510A and paddles 520A, 522A and been woven through the collar511D and paddle frames 524A.

The retention body 560A includes a locking aperture 561A for receivingthe retaining nut 562A. The locking aperture 561A has a generallyrectangular shape and includes two opposing locking channels 561B thatreceive the attachment portions 524C of the paddle frames 524A. Atransverse locking channel 561C formed in the bottom of the retentionbody 560A has the same width as the locking channels 561B. The paddleframes 524A include notches 524D in the attachment portions 524C thatform hook portions 524E that engage the transverse locking channel 561Ato secure the paddle frames 524A to the cap 514A.

The retaining nut 562A includes a rectangular locking body 563Aextending distally from a flange 563B. The locking body 563A isconfigured to slidably engage the locking aperture 561A of the retentionbody 560A while leaving the locking channels 561B unobstructed. Thus,the locking body 563A can be inserted into the locking aperture 561A tolock the attachment portions 524C of the paddle frames 524A within thelocking channels 561B. Notches 563C in the flange 563B accommodate theattachment portions 524C of the paddle frames 524A. The threaded bore564A is formed through the retaining nut 562A to receive the retainingbolt 566A.

The retaining bolt 566A includes a threaded portion 568A extending fromthe flange 567A. The threaded portion 568A is inserted through theopening 527B in the distal portion 527A to threadably engage thethreaded bore 564A of the retaining nut 562A. The flange 567A has arounded shape that provides a rounded end to the distal portion 505A ofthe device 500A. The flange 567A includes openings 567B for receiving atool (not shown) that engages the bolt 566A so that the bolt 566A can beturned during assembly to couple the components of the cap 514Atogether.

To assemble the paddle frames 524A and cap 514A to the distal portion527A, the paddle frames 524A are squeezed to narrow the width of theattachment portion 524C so that the attachment portions 524C can beinserted into the locking channels 561B of the locking aperture 561A.When the paddle frames 524A are allowed to expand, the attachmentportions 524C expand outward so that the notches 524D engage theretention body 560A and the hook portions 524E engage the transverselocking channel 561C. The retaining nut 562A is then inserted into thelocking aperture 561A with the locking portion 563A arranged between thetwo attachment portions 524C of each paddle frame 524A, thereby lockingthe paddle frames 524A in engagement with the retention body 560A. Theassembled paddle frames 524A, retention body 560A, and retaining nut562A are placed on the distal portion 527A so that the threaded bore564A aligns with the opening 527B and the threaded portion 568A of thebolt 566A is inserted through the opening 527B to threadably engage thethreaded bore 564A. The bolt 566A is then tightened until the flange567A engages the retention body 560A and the cap 514A is securelyassembled to the distal portion 527A.

Referring now to FIGS. 203 and 204, portions of the cover 540A are showncut from flat sheets of material. The cover 540A includes the outercover 541A and the inner cover 543A. Each of the covers 541A, 543Ainclude different shaped segments or portions to attach to differentportions of the device 500A. In particular, the covers 541A, 543A areshaped to smooth transitions between portions of the device 500A toreduce catch points and provide a smoother exterior to the device 500.

The various segments of the covers 541A, 543A extend from a middleportion that is shaped to attach to an end of the device 500A. In otherembodiments, the portion of the cover 541A, 543A that attaches to an endof the device 500A is located at an end of the covers 541A, 543A or maybe located anywhere between the middle and ends of the covers 541A,543A. Various portions of the covers 541A, 543A may be shaped to wraparound portions of the device 500A. The cover 540A can be made of anysuitable material, such as a polyethylene cloth of a fine mesh. Incertain embodiments, the cover is formed out of a single piece ofmaterial. In other embodiments, the cover may be formed of any number ofpieces of material that are attached to the device and/or joinedtogether by any suitable means, such as by stitching, adhesives,welding, or the like.

Referring to FIGS. 60C and 204, the outer cover 541A extends outwardfrom a middle portion 580 to end portions 588. The middle portion 580 isshaped to be attached to the cap 514A of the device 500A. Outer paddleportions 582 extend from the middle portion 580 to inner paddle andinside clasp portions 584. The inner paddle and inside clasp portions584 extend from the outer paddle portions 582 to outside moveable claspportions 586. The outside moveable clasp portions 586 extend from theinner paddle portions 584 to the end portions 588.

The outer paddle portions 582 include wing portions 583 that extendlaterally to a width that is wider than the other portions of the outercover 541A so that the outer paddle portions 582 can attach to the outerpaddles 520A and paddle frames 524A of the device 500A. The inner paddleportions 584 attach to the inner paddles 522A, stationary arms 532C, andthe inside surface (the side with the barbs) of the moveable arms 534C.The outside clasp portions 586 attach to the outside surface (the sidewithout the barbs) of the moveable arms 534C of the clasps 530C. Theends 588 of the outer cover 541A terminate near the joint portion 538Cof the clasp 530C on the outside of the clasps 530C. The inner paddleand inside clasp portions 584 include openings 585 that allow the barbs536C of the clasps 530C to protrude through the outer cover 541A toengage tissue of the native heart valve.

Referring to FIGS. 60C and 203, the inner cover 543A extends outwardfrom a middle portion 590 to end portions 598. The middle portion 590 isconfigured to be attached to the collar 511D of the device 500A.Openings 591 in the middle portion 590 expose the protrusions 511E fromthe collar 511D when the middle portion 590 is attached to the collar511D so that the protrusions 511E can be engaged by the delivery device502A. Coaption portions 592 extend from the middle portion 590 toflexible hinge portions 594. Holes 593 along the edges of the coaptionportions 592 allow each of the coaption portions 592 to be joinedtogether after being folded around the coaption element 510A, such as,for example, by stitches 545A. The flexible hinge portions 594 extendfrom the coaption portions 592 to transition portions 596. Thetransition portions 596 extend from the flexible hinge portions 594 tothe end portions 598. Holes 597 along the edges of the transitionportions 596 allow each of the transition portions 596 to be wrappedaround the inner paddle 522A and ends of the clasp 536C and secured toitself by stitches or other suitable securing means. The flexible hingeportions 594 bridge the gaps between the coaption element 510A and theclasps 530C when the device 500A is opened, as can be seen in FIG. 198.

Referring now to FIGS. 62A-64C, an implantable device 700 is shown. Theimplantable device 700 has paddles 702 that open and close to graspleaflets 20, 22 against barbed clasps or gripping devices 704. Thepaddles 702 move to create an opening 706 between the paddles 702 andgripping devices 704 in which the leaflets 20, 22 can be grasped. Thedevice 700 can be configured to close a wide gap 26 (FIG. 6) in thenative heart valve MV, TV. In addition, the implantable device 700 caninclude any other features for a device discussed in the presentapplication, and the device 700 can be positioned to engage valveleaflets 20, 22 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application). The device700 can include any other features for an implantable prosthetic devicediscussed in the present application, and the device 700 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

Referring to FIG. 62A, the paddles 702 of the device 700 are pivotedoutward in the direction X to create an opening 706 between the paddles702 and the gripping members 704 having a width W. The width W can be,for example, between about 5 mm and about 15 mm, such as between 7.5 mmand about 12.5 mm, such as about 10 mm. In alternative embodiments, thewidth W can be less than 5 mm or greater than 15 mm.

Referring to FIG. 62B, the paddles 702 of the device 700 are movedoutward in the direction Z such that the opening 706 has a width H. Thewidth H can be, for example, between about 10 mm and about 25 mm, suchas between about 10 mm and about 20 mm, such as between about 12.5 mmand about 17.5 mm, such as about 15 mm. In alternative embodiments, thewidth H can be less than 10 mm or more than 25 mm. In certainembodiments, the ratio between the width H and the width W can be about5 to 1 or less, such as about 4 to 1 or less such as about 3 to 1 orless, such as about 2 to 1 or less, such as about 1.5 to 1 or less, suchas about 1.25 to 1 or less, such as about 1 to 1. The device 700 can beconfigured such that the paddles 702 are pivoted outward in thedirection X and then moved outward in the direction Z to create theopening 706 having a width H between the paddles 702 and the grippingmembers 704. Alternatively, the device 700 can be configured such thatthe paddles are moved outward in the direction Z and then pivotedoutward in the direction X to create width H between the paddles 702 andgripping members 704. In addition, the device 700 can be configured suchthat the paddles 702 are pivoted outward in the direction X and movedoutward in the direction Z simultaneously to create the width H betweenthe paddles 702 and the gripping members 704.

FIGS. 63A-63C illustrate an implantable device 700 in which the paddles702 are pivoted outward in the direction X, and, subsequently, movedoutward in the direction Z to create a wider opening 706. FIG. 63Aillustrates the implantable device 700 in a closed position, such thatthe paddles 702 are engaging the gripping members 704. Referring to FIG.63B, the paddles 702 are pivoted outward in the direction X to create anopening 706 having a width W for receiving valve tissue. Referring toFIG. 63C, after the paddles 702 are pivoted outward in the direction X,the paddles 702 are moved outward in the direction Z such that theopening 706 has a width H. After valve tissue is received in theopenings 706 between the paddles 702 and the gripping members 704, thevalve repair device is moved back to the closed position (as shown inFIG. 63A) to secure the valve repair device 700 to the valve tissue. Theimplantable device 700 can include any other features for an implantabledevice discussed in the present application, and the implantable device700 can be positioned to engage valve tissue 20, 22 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

FIGS. 64A-64C illustrate an implantable device 700 in which the paddles702 are moved outward in the direction Z, and, subsequently, pivotedoutward in the direction X to create a wider opening 706. FIG. 64Aillustrates the implantable device 700 in a closed position, such thatthe paddles 702 are engaging the gripping members 704. Referring to FIG.64B, the paddles 702 are moved outward in the direction Z to create anopening 706 having a width W for receiving valve tissue. Referring toFIG. 64C, after the paddles 702 are moved outward in the direction Z,the paddles 702 are pivoted outward in the direction X such that theopening 706 has a width H. After valve tissue is received in theopenings 706 between the paddles 702 and the gripping members 704, theimplantable device 700 is moved back to the closed position (as shown inFIG. 64A) to secure the implantable device 700 to the valve tissue. Theimplantable device 700 can include any other features for an implantabledevice discussed in the present application, and the implantable device700 can be positioned to engage valve tissue 20, 22 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

While FIGS. 63A-63C illustrate a device 700 in which the paddles 702 arepivoted and then spread apart, and FIGS. 64A-64C illustrate a device 700in which the paddles 702 are spread apart and then pivoted, inalternative embodiments, a device 700 can include paddles 702 that canbe spread apart and pivoted simultaneously. In addition, in certainembodiments, the paddles 702 can be spread apart and pivotedindependently of each other. That is, in the embodiments for the valverepair device 700 shown in FIGS. 63A-63C and 64A-64C, as well as theembodiment in which the spreading apart and pivoting of each paddle 702is completed simultaneously, the paddles 702 can be controlledindependently of each other.

Referring now to FIGS. 65-83, the exemplary implantable device 500 isshown in the closed condition. Referring now to FIGS. 65-66, the device500 extends from a proximal portion 505 to a distal portion 507 andincludes a coaption portion 510, inner paddles 522, outer paddles 520,and paddle frames 524. In some embodiments, the outer paddles 520 extendto and/or around the paddle frames 524 and can have more than one layerto surround the paddle frames 524. The proximal portion 505 can includea collar 511 for attaching a delivery device (not shown). The distalportion 507 can include a cap 514 that is jointably attached to theouter paddles 520 and is engaged by an actuation wire (not shown) toopen and close the device 500 to facilitate implantation in the mitralvalve as described in the present application.

Referring now to FIGS. 67-68, a front view of the device 500 is shown.The device 500 has a shape that is substantially symmetrical around avertical front-to-back plane 550 and is generally narrower at the distalportion 507 than the proximal portion 505. The shape of the coaptionelement 510 and paddle frames 524 is generally rounded to prevent thedevice 500 from catching or snagging on structures of the heart, such asthe chordae tendineae, during implantation. For this reason, theproximal collar 511 (FIG. 68) and cap 514 (FIG. 68) also have roundedges. When viewed from the front or back, the paddle frames 524 can beseen to have a generally rounded shape, extending upwards and outwardsfrom the distal portion 507 to approximately coincide with the shape ofthe coaption element 510 when viewed from the front or back. Thus, thecoaption element 510 and paddle frames 524 generally define the shape ofthe device 500 when viewed from the front or back. In addition, therounded shape of the paddle frames 524 and the corresponding roundedshape of the coaption element can distribute leaflet stress across awider surface. In other exemplary embodiment, the paddle frames 524and/or the coaption element 510 can have other shapes.

Referring now to FIG. 69, a side view of the device 500 is shown. Aswith the front and back views (FIGS. 67-68), the device 500 has a shapethat is substantially symmetrical around a vertical side-to-side plane552 when viewed from the side. The distal portion 507 is also generallynarrower than the proximal portion 505 when the device 500 is viewedfrom the side. The coaption element 510 optionally also has a generallytapering shape that narrows toward the distal portion 507 of the device500. However, in other exemplary embodiments, the coaption element doesnot taper as it extends from the proximal portion of the device to thedistal portion of the device.

The generally rounded features of the device 500 are furtherdemonstrated by the round shape of the paddles 520, 522 where the innerand outer paddles 520, 522 are joined together and the round shape ofthe paddle frames 524. However, the paddles 520, 522 and paddle frames524 can take a wide variety of different forms. For example, the paddles520, 522 and the paddle frames 524 can be rounded along the top edges,but be flat or substantially flat on the sides of the paddles 520, 522and/or the paddle frames. By making the paddles 520, 522 flat orsubstantially flat on the sides, two devices can be implantedside-by-side on the mitral valve leaflet, with the two devices sittingsubstantially flush against each other.

The closed paddles 520, 522 form gaps 542 between the inner paddles 522and the coaption element 510 that are configured to receive nativetissue. As can be seen in FIG. 69, the narrowing of the coaption element510 gives the gaps 542 a somewhat teardrop shape that increases in widthas the gaps 542 approach the distal portion 507 of the device. Thewidening of the gaps 542 toward the distal portion 507 allows thepaddles 520, 522 to contact tissue grasped in the gaps 542 nearer to theproximal portion 505.

The paddle frames 524 extend vertically from the distal portion 507toward the proximal portion 505 until approximately a middle third ofthe device 500 before bending or flaring outward so that the connectionportion of the frames 524 passes through gaps 544 formed by the innerpaddles 522 folded inside of the outer paddles 520. However, in otherembodiments the connection of the frames are positioned inside the innerpaddles 522 or outside the outer paddles 520. The outer paddles 520 havea rounded shape that is similar to that of the coaption element 510 whenviewed from the front or back (FIGS. 67-68). Thus, the device 500 has asubstantially round shape. The round shape of the device 500 isparticularly visible when the device 500 is viewed from the top (FIGS.70-71) or bottom (FIGS. 72-73).

Referring now to FIGS. 70-71, top views of the device 500 are shown. Thedevice 500 has a shape that is substantially symmetrical around afront-to-back plane 550 and is also substantially symmetrical around aside-to-side plane 552 when viewed from the top. An opening 519A in thecoaption element 510 is visible at the proximal portion 505 of thedevice 500. As can be seen in FIG. 70, the coaption element 510 can behollow inside. The proximal collar 511 shown in FIG. 71 can be securedto the coaption element 510 to close off the coaption element 510.

In one exemplary embodiment, the coaption element is not planar and hasall curved surfaces. For example, the coaption elements 510 illustratedherein can be formed of a series of blended surfaces have a variety ofdifferent radii of curvature. The coaption element 510 has a generallyoval-shape when viewed from the top. However, in other exemplaryembodiments, the coaption element 510 can have other shapes when viewedfrom the top. For example, the coaption element can have a rectangular,square, diamond, elliptical, or any other shape. The paddle frames 224each have an arcuate shape with a smaller radius than the coaptionelement 510 so that the gaps 542 formed between the inner paddles 522and paddle frames 524 and the coaption element 510 taper as theyapproach left 551 and right 553 sides of the device 500. Thus, nativetissue, such as the leaflets 20, 22 tend to be pinched between thepaddle frames 524 and the coaption element 510 towards the left andright sides 551, 553 of the device 500.

Referring now to FIGS. 72-73, bottom views of the device 500 are shown.As with the top views (FIGS. 70-71), the device 500 has a shape that issubstantially symmetrical around the front-to-back plane 550 and is alsosubstantially symmetrical around the side-to-side plane 552 when viewedfrom the bottom. The cap 514 is shown in FIG. 73 and can jointablyattach to the outer paddles 520 and the paddle frames 524.

The paddle frames 524 extend outward from the distal portion 507 of thedevice 500 to the left and right sides 551, 553 at a narrow or slightangle from the side-to-side plane 552. The paddle frames 524 extendfurther away from the side-to-side plane 552 as the paddle frames 524extend toward the proximal portion of the device 500 (FIG. 69) toultimately form the arcuate shape seen in FIGS. 70-71.

Referring now to FIGS. 74-83, perspective and cross-sectional views ofthe device 500 are shown. Referring now to FIG. 74, the device 500 isshown sliced by cross-section plane 75 near the proximal portion of thecoaption element 510. Referring now to FIG. 75, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 75 in FIG.74. At the location of the plane 75, the coaption element 510 has agenerally round shape with lobes arranged along the front-to-back plane550. The gaps 542 between the paddle frames 524 and coaption element 510form a crescent-like shape with a central width 543. As noted above, thegaps 542 narrow as the gaps 542 approach the left and right sides 551,553.

Referring now to FIG. 76, the device 500 is shown sliced bycross-section plane 77 positioned about three-quarters of the waybetween the distal portion 507 and the proximal portion 505 of thecoaption element 510. Referring now to FIG. 77, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 77 in FIG.76. At the location of the plane 75, the coaption element 510 has agenerally oval shape oriented along the side-to-side plane 552. The gaps542 between the paddle frames 524 and coaption element 510 form acrescent-like shape with a central width 543 that is less than thecentral width 543 seen in FIG. 75. At the location of the plane 77, thewidth 543 of the gaps 542 is narrower towards the center of the device,widens somewhat as the gaps 542 approach the left and right sides 551,553 before narrowing again. Thus, the native tissue is pinched in thecenter of the gaps 542 about three-quarters of the way up the coaptionelement 510.

Referring now to FIG. 78, the device 500 is shown sliced bycross-section plane 79 positioned about half of the way between thedistal portion 507 and the proximal portion 505 of the coaption element510. Referring now to FIG. 79, a cross-sectional view of the device 500is shown as viewed from cross-section plane 79 in FIG. 78. At thelocation of the plane 79, the coaption element 510 has a generally ovalshape oriented along the side-to-side plane 552. The paddle frames 524can be seen near the left and right sides 551, 553 very close to or incontact with the coaption element 510. The gaps 542 are generallycrescent shaped and are wider than the gaps 542 viewed along the plane77 (FIG. 77.)

Referring now to FIG. 80, the device 500 is shown sliced bycross-section plane 81 positioned about one-quarter of the way betweenthe distal portion 507 and the proximal portion 505 of the coaptionelement 510. Referring now to FIG. 81, a cross-sectional view of thedevice 500 is shown as viewed from cross-section plane 81 in FIG. 80. Atthe location of the plane 81, the coaption element 510 has a generallyoval shape oriented along the side-to-side plane 552 that is narrowerthan the oval shape seen in FIG. 77. The paddle frames 524 can be seennear the left and right sides 551, 553 very close to or in contact withthe coaption element 510. The gaps 542 are generally crescent shaped andare wider than the gaps 542 viewed along the plane 79 (FIG. 79.)

Referring now to FIG. 82, the device 500 is shown sliced bycross-section plane 83 positioned near the distal portion 507 of thecoaption element 510. Referring now to FIG. 83, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 83 in FIG.82. At the location of the plane 83, the coaption element 510 has agenerally oval shape oriented along the side-to-side plane 552 that isnarrower than the oval shape seen in FIG. 79 as the coaption element 510tapers toward the distal portion 507 of the device 500. The paddleframes 524 can be seen near the left and right sides 551, 553 very closeto or in contact with the coaption element 510. While the inner paddles522 are not visible in FIG. 81, the gaps 542 are generally crescentshaped and are wider than the gaps 542 viewed along the plane 81 (FIG.81.)

Referring now to FIGS. 65A, 66A, 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A,76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, the exemplary implantabledevice 500A is shown in the closed condition. Referring now to FIGS. 65Aand 66A, the device 500A extends from a proximal portion 505A to adistal portion 507A and includes a coaption portion 510A, inner paddles522A, outer paddles 520A, and paddle frames 524A. The proximal portion505A can include a collar 511D for attaching a delivery device (notshown). The distal portion 507A can include a cap 514A that is jointablyattached to the outer paddles 520A and is engaged by an actuation wire(not shown) to open and close the device 500A to facilitate implantationin the mitral valve as described in the present application.

Referring now to FIGS. 67A and 68A, front views of the device 500A areshown. The device 500A has a shape that is substantially symmetricalaround a vertical front-to-back plane 550A and is generally narrower atthe distal portion 507A than it is along the paddle frames 524A. Theshape of the coaption element 510A and paddle frames 524A is a generallyrounded rectangular shape to prevent the device 500A from catching orsnagging on structures of the heart, such as the chordae tendineae,during implantation. For this reason, the proximal collar 511D (FIG.68A) and cap 514A (FIG. 68A) can also have round edges. When viewed fromthe front or back, the paddle frames 524A can be seen to have agenerally rounded rectangular shape, extending upwards and outwards fromthe distal portion 507A to a shape that has sides that are wider thanand approximately parallel to the coaption element 510A when viewed fromthe front or back. Thus, the paddle frames 524A generally define theshape of the device 500A when viewed from the front or back. Inaddition, the rounded rectangular shape of the paddle frames 524A candistribute leaflet stress across a wider surface. In other exemplaryembodiment, the paddle frames 524A and/or the coaption element 510A canhave other shapes.

As with the front and back views (FIGS. 67A and 68A), the device 500Ahas a shape that is substantially symmetrical around a verticalside-to-side plane 552A (FIG. 70A) when viewed from the side (e.g., FIG.47A). The distal portion 507A is also generally narrower than theproximal portion 505A when the device 500A is viewed from the side. Inthe embodiment illustrated in FIG. 48B, the coaption element 510A doesnot taper as it extends from the proximal portion 505A of the device500A to the distal portion 507A of the device 500A. However, in otherexemplary embodiments, the coaption element does taper as it extendsfrom the proximal portion of the device to the distal portion of thedevice (e.g., FIG. 47).

The generally rounded features of the device 500A are furtherdemonstrated by the rounded shape of the paddles 520A, 522A where theinner and outer paddles 520A, 522A are joined together. However, thepaddles 520A, 522A and paddle frames 524A can take a wide variety ofdifferent forms. For example, the paddles 520A, 522A and the paddleframes 524A can be rounded along the top edges and be flat orsubstantially flat on the sides (e.g., the sides of the paddle frames524A arranged at the front and back sides of the device 500A). By makingthe paddles 520A, 522A flat or substantially flat on the sides, twodevices can be implanted side-by-side on the mitral valve leaflet, withthe two devices sitting substantially flush against each other.

The closed paddles 520A, 522A form gaps 542A between the inner paddles522A and the coaption element 510A that are configured to receive nativetissue. As can be seen in FIGS. 48B and 48F, the proximal end of thecoaption element 510A has an approximately dog-bone shape so that thegaps 542A are narrower toward the proximal portion 505A than as the gaps542A approach the distal portion 507A of the device. The narrowing ofthe gaps 542A toward the attachment portion 507A allows the paddles520A, 522A to contact tissue grasped in the gaps 542A nearer to theproximal portion 505A.

The paddle frames 524A extend vertically from the distal portion 507Atoward the proximal portion 505A until approximately a middle third ofthe device 500A before bending or flaring outward so that a connectionportion 524B of the frames 524A passes through gaps 544A formed by theinner paddles 52A folded inside of the outer paddles 520A. However, inother embodiments the connections of the frames are positioned insidethe inner paddles 522A or outside the outer paddles 520A. The outerpaddles 520A have a rounded rectangular shape that is similar to that ofthe coaption element 510A when viewed from the front or back (FIGS. 67Aand 68A). Thus, the device 500A has a substantially rounded rectangularshape. The rounded rectangular shape of the device 500A is particularlyvisible when the device 500A is viewed from the top (FIGS. 70A and 71A)or bottom (FIGS. 72A and 73A).

Referring now to FIGS. 70A and 71A, top views of the device 500A areshown. The device 500A has a shape that is substantially symmetricalaround a front-to-back plane 550A and is also substantially symmetricalaround a side-to-side plane 552A when viewed from the top. A proximalopening 519C in the coaption element 510A is visible at the proximalportion 505A of the device 500A. The actuation wire 512A is receivedthrough the opening 519C so that the coaption element 510A wraps aroundthe actuation wire 512A. In some embodiments, the opening 519C is formedby inserting the actuation wire 512A between the folded and overlappinglayers of the strip of material 501A (described in detail below). Inother embodiments, the opening 519C is formed by shape-setting thefolded layers of the strip of material 501A forming the coaption element510A around a blank or jig to give the coaption element 510A a generallyrounded shape. The proximal collar 511D shown in FIG. 71A can be securedto the coaption element 510A to close off the coaption element 510A. Theproximal collar 511D includes attachment portions 513A that engage withopenings 546A formed by the folded layers of the strip of material 501Athat form the coaption element 510A. In some embodiments, the attachmentportions 513A are holes in the collar 511D so that the strip of material501A must be inserted through the collar 511D before folding the stripof material 501A during assembly of the device 500A. In someembodiments, the attachment portions 513A are open slots (e.g., theattachment portions 524B of the paddle frames 524A) that receive thestrip of material 501A before or after folding the strip of material501A.

As is noted above, the coaption element 510A has a generally rectangularshape when viewed from the top. In other exemplary embodiments, thecoaption element 510A can have other shapes when viewed from the top.For example, the coaption element can have a round, square, diamond,elliptical, or any other shape. The paddle frames 224A each have arounded rectangular shape when viewed from the top so that the paddleframes 224A surround the rectangular coaption element 510A. Thus, nativetissue, such as the leaflets 20, 22 tend to be pinched or compressedevenly in the gaps 542A formed between the inner paddles 522A and paddleframes 524A and the coaption element 510A.

Referring now to FIGS. 72A and 73A, bottom views of the device 500A areshown. As with the top views (FIGS. 70A and 71A), the device 500A has ashape that is substantially symmetrical around the front-to-back plane550A and is also substantially symmetrical around the side-to-side plane552A when viewed from the bottom. A distal portion 527A of the strip ofmaterial 501A includes an aperture 527B for receiving the cap 514A shownin FIG. 73A.

The paddle frames 524A extend outward from the distal portion 507A ofthe device 500A to the left and right sides 551A, 553A at a narrow orslight angle from the side-to-side plane 552A. The paddle frames 524Aextend further away from the side-to-side plane 552A while maintaining agenerally constant distance relative to the front-to-back plane 550A asthe paddle frames 524A extend toward the proximal portion 505A of thedevice 500A (FIG. 65A) to ultimately form the rounded rectangle shapeseen in FIGS. 70A and 71A.

In one exemplary embodiment, the dimensions of the device 500A areselected to minimize the number of implants that a single patient willrequire (preferably one), while at the same time maintaining lowtransvalvular gradients. In one exemplary embodiment, theanterior-posterior distance Y_(47I) of the device 500A at the widest isless than 10 mm, and the medial-lateral distance Y_(67C) of the spacerat its widest is less than 6 mm. In one exemplary embodiment, theoverall geometry of the device 500A can be based on these two dimensionsand the overall shape strategy described above. It should be readilyapparent that the use of other anterior-posterior distance Y_(47I) andmedial-lateral distance Y_(67C) as starting points for the device 500Awill result in a device having different dimensions. Further, usingother dimensions and the shape strategy described above will also resultin a device having different dimensions.

Tables D and E provide examples of values and ranges for dimensions ofthe device 500A and components of the device 500A for some exemplaryembodiments. However, the device 500A can have a wide variety ofdifferent shapes and sizes and need not have all or any of thedimensional values or dimensional ranges provided in Tables D and E.Table D provides examples of linear dimensions Y in millimeters andranges of linear dimensions in millimeters for the device 500A andcomponents of the device 500A. Table B provides examples of radiusdimensions S in millimeters and ranges of radius dimensions inmillimeters for the device 500A and components of the device 500A. Thesubscripts for each of the dimensions indicates the drawing in which thedimension first appears.

TABLE D Linear Dimensions (mm) Range A Range B Range C Range D Example(max) (min) (max) (min) (max) (min) (max) (min) Y_(47A) 2.58 1.29 3.871.94 3.23 2.32 2.84 2.45 2.71 Y_(47B) 1.43 0.72 2.15 1.07 1.79 1.29 1.571.36 1.50 Y_(47C) 3.75 1.88 5.63 2.81 4.69 3.38 4.13 3.56 3.94 Y_(47D)0.35 0.18 0.53 0.26 0.44 0.32 0.39 0.33 0.37 Y_(47E) 0.71 0.36 1.07 0.530.89 0.64 0.78 0.67 0.75 Y_(47F) 1.07 0.54 1.61 0.80 1.34 0.96 1.18 1.021.12 Y_(47G) 7.68 3.84 11.52 5.76 9.60 6.91 8.45 7.30 8.06 Y_(47H) 5.412.71 8.12 4.06 6.76 4.87 5.95 5.14 5.68 Y_(47I) 9.16 4.58 13.74 6.8711.45 8.24 10.08 8.70 9.62 Y_(47J) 0.72 0.36 1.08 0.64 0.90 0.65 0.790.68 0.76 Y_(67A) 1.61 0.81 2.42 1.21 2.01 1.45 1.77 1.53 1.69 Y_(67B)3.25 1.63 4.88 2.44 4.06 2.93 3.58 3.09 3.41 Y_(67C) 5.90 2.95 8.85 4.437.38 5.31 6.49 5.61 6.20 Y_(67D) 15.21 7.60 22.81 11.41 19.01 13.6916.73 14.45 15.97 Y_(67E) 3.25 1.63 4.88 2.44 4.06 2.93 3.58 3.09 3.41Y_(68A) 14.04 7.02 21.06 10.53 17.55 12.64 15.44 13.34 14.74 Y_(71A)4.50 2.25 6.75 3.38 5.63 4.05 4.95 4.28 4.73 Y_(72A) 2.50 1.25 3.75 1.883.13 2.25 2.75 2.38 2.63 Y_(114A) 4.34 2.17 6.50 3.25 5.42 3.90 4.774.12 4.55 Y_(114B) 13.28 6.64 19.92 9.96 16.60 11.95 14.61 12.62 13.94Y_(118A) 14.79 7.39 22.18 11.09 18.48 13.31 16.27 14.05 15.53

TABLE E Radius Dimensions (mm) Range A Range B Range C Range D Example(max) (min) (max) (min) (max) (min) (max) (min) S_(47A) 0.74 0.37 1.110.56 0.93 0.67 0.81 0.70 0.78 S_(47B) 0.68 0.34 1.02 0.51 0.85 0.61 0.750.65 0.71 S_(47C) 1.10 0.55 1.65 0.83 1.38 0.99 1.21 1.05 1.16 S_(47D)5.62 2.81 8.43 4.22 7.03 5.06 6.18 5.34 5.90 S_(47E) 0.96 0.48 1.44 0.721.20 0.86 1.06 0.91 1.01 S_(71A) 0.63 0.31 0.94 0.47 0.78 0.56 0.69 0.590.66 S_(71B) 2.07 1.04 3.11 1.55 2.59 1.86 2.28 1.97 2.17 S_(73A) 1.880.94 2.81 1.41 2.34 1.69 2.06 1.78 1.97 S_(114A) 5.62 2.81 8.43 4.227.03 5.06 6.18 5.34 5.90 S_(114B) 6.00 3.00 9.00 4.50 7.50 5.40 6.605.70 6.30 S_(114C) 3.15 1.58 4.73 2.36 3.94 2.84 3.47 2.99 3.31 S_(117A)1.15 0.58 1.73 0.86 1.44 1.04 3.27 1.09 1.21 S_(117B) 2.69 1.35 4.042.02 3.36 2.42 2.96 2.56 2.82

Referring now to FIGS. 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and83A, perspective and cross-sectional views of the device 500A are shown.Referring now to FIG. 74A, the device 500A is shown sliced bycross-section plane 75A near the proximal portion of the coaptionelement 510A. Referring now to FIG. 75A, a cross-sectional view of thedevice 500A is shown as viewed from cross-section plane 75A in FIG. 74A.At the location of the plane 75A, the coaption element 510A has agenerally rounded rectangular shape. The gaps 542A between the innerpaddles 522A and coaption element 510A have a width 542B. As notedabove, the gaps 542A have a generally consistent width.

Referring now to FIG. 76A, the device 500A is shown sliced bycross-section plane 77A positioned about three-quarters of the waybetween the distal portion 507A and the proximal portion 505A of thecoaption element 510A. Referring now to FIG. 77A, a cross-sectional viewof the device 500A is shown as viewed from cross-section plane 77A inFIG. 76A. As can be seen in FIGS. 76A and 77A, the strip of material501A forming the device 500A is overlapped to form four layers in thearea of the coaption element 510A. A single layer of the strip ofmaterial 501A forms each of the inner paddle 522A and the outer paddle520A. At the location of the plane 75A, the coaption element 510A has agenerally rectangular shape oriented along the side-to-side plane 552A.The gaps 542A between the inner paddle 522A and the coaption element510A are visible. The gaps 542A between the inner paddles 522A andcoaption element 510A have a width 542B that is greater than the width542B seen in FIG. 75A. The gaps 544A between the outer and inner paddles520A, 522A have a generally consistent width 544B for receiving theattachment portion 524B of the paddle frames 524A.

Referring now to FIG. 78A, the device 500A is shown sliced bycross-section plane 79A positioned about half of the way between thedistal portion 507A and the proximal portion 505A of the device 500A.Referring now to FIG. 79A, a cross-sectional view of the device 500A isshown as viewed from cross-section plane 79A in FIG. 78A. As can be seenin FIGS. 78A and 79A, the strip of material 501A forming the device 500Ais overlapped to form four layers in the area of the coaption element510A, two layers in the area of the inner paddle 522A, and one layer inthe area of the outer paddle 520A. At the location of the plane 79A, thecoaption element 510A has a generally rectangular shape oriented alongthe side-to-side plane 552A. The gaps 542A between the inner paddles522A and the coaption element 510A have a width 542B that is the same orabout the same as the width 542B seen in FIG. 77A.

Referring now to FIG. 80A, the device 500A is shown sliced bycross-section plane 81A positioned about one-quarter of the way betweenthe distal portion 507A and the proximal portion 505A of the device500A. Referring now to FIG. 81A, a cross-sectional view of the device500A is shown as viewed from cross-section plane 81A in FIG. 80A. As canbe seen in FIGS. 80A and 81A, the strip of material 501A forming thedevice 500A is overlapped to form four layers in the area of thecoaption element 510A, two layers in the area of the inner paddle 522A,and the outer paddle 520A is formed by a single layer. At the locationof the plane 81A, the coaption element 510A has a generally rectangularshape oriented along the side-to-side plane 552A. The gaps 542A betweenthe inner paddle 522A and coaption element 510A have a width 542B thatis about the same as the central width 542B seen in FIG. 79A.

Referring now to FIG. 82A, the device 500A is shown sliced bycross-section plane 83A positioned about one-quarter of the way betweenthe distal portion 507A and the proximal portion 505A of the device500A. Referring now to FIG. 83A, a cross-sectional view of the device500A is shown as viewed from cross-section plane 83A in FIG. 82A. As canbe seen in FIGS. 82A and 83A, the strip of material 501A forming thedevice 500A is overlapped to form four layers in the area of thecoaption element 510A, two layers in the area of the inner paddle 522A,and a single layer forms the outer paddle 520A. At the location of theplane 83A, the coaption element 510A has a generally rectangular shapeoriented along the side-to-side plane 552A. The gaps 542A between theinner paddles 522A and coaption element 510A form an arcuate shape witha width 542B that is about the same as the central width 542B seen inFIG. 81A.

Referring now to FIGS. 84-88, 86A, 87A, and 88A, exemplary implantabledevices 100, 500, 500A are shown without clasps or articulable grippingmembers. Rather, the exemplary devices 100, 500, 500A shown in FIGS.84-88, 86A, 87A, and 88A, have barbs or gripping members 800/800A and/or802/802A integrated into portions of the coaption element or paddles ofthe anchor portion of the devices to facilitate grasping of the tissueof the native heart valve.

Referring now to FIG. 84, an exemplary implantable device 100 is shownthat does not include articulable clasps or gripping elements. Asdescribed above, the device 100 is deployed from a delivery sheath ormeans for delivery 102 and includes a coaption portion 104 and an anchorportion 106. The coaption portion 104 of the device 100 includes acoaption element or means for coapting 110 that is adapted to beimplanted between the leaflets 20, 22 of the native mitral valve MV andis slidably attached to an actuation wire or shaft 112 that extendsthrough the coaption element or means for coapting 110 to a distal cap114.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between the distal cap 114 and thecoaption element or means for coapting 110. The anchor portion 106 isactuatable between open and closed conditions and can take a widevariety of forms, such as, for example, paddles, gripping elements, orthe like. Actuation of the actuation wire or means for actuating 112opens and closes the anchor portion 106 of the device 100 to grasp themitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 100shown in FIG. 84 includes barbed portions 800 arranged on the coaptionelement or means for coapting 110, with each side of the coaptionelement or means for coapting 110 having at least one barbed portion800. When the anchor portion 106 of the device 100 is closed, tissuegrasped between the inner paddles 122 and the coaption element or meansfor coapting 110 is pressed against the barbed portions 800. The barbedportions 800 can be sharp so that they engage—and in some embodiments,pierce—the native tissue and prohibit the tissue from retracting fromthe device 100. In some embodiments, the barbed portions 800 are angleddownward to increase engagement with the native tissue.

Referring now to FIG. 85, the exemplary implantable device 100 is shownwithout separate articulable clasps. As described above, the device 100is deployed from a delivery sheath or means for delivery 102 andincludes a coaption portion 104 and an anchor portion 106. The coaptionportion 104 of the device 100 includes a coaption element or means forcoapting 110 that is adapted to be implanted between the leaflets 20, 22of the native mitral valve MV and is slidably attached to an actuationwire or shaft 112 that extends through the coaption element or means forcoapting 110 to a distal cap 114.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between the distal cap 114 and thecoaption element or means for coapting 110. The anchor portion 106 isactuatable between open and closed conditions and can take a widevariety of forms, such as, for example, paddles, gripping elements, orthe like. Actuation of the actuation wire or means for actuating 112opens and closes the anchor portion 106 of the device 100 to grasp themitral valve leaflets 20, 22 during implantation.

Rather than separate articulable clasps or gripping elements, the device100 shown in FIG. 85 includes barbed portions 800 arranged on the innerpaddles 122, with each inner paddle 122 having at least one barbedportion 800. When the anchor portion 106 of the device 100 is closed,tissue grasped between the inner paddles 122 and the coaption element ormeans for coapting 110 is pressed against the barbed portions 800. Thebarbed portions 800 are sharp so that they engage—and in someembodiments, pierce—the native tissue and prohibit the tissue fromretracting from the device 100. In some embodiments, the barbed portions800 are angled downward to increase engagement with the native tissue.

Referring now to FIG. 86, the exemplary implantable device 500 is shownthat does not include articulable clasps or gripping elements. Asdescribed above, the device 500 includes a coaption portion 504 and ananchor portion 506. The coaption portion 504 of the device 500 includesa coaption element 510 that is adapted to be implanted between theleaflets 20, 22 of the native mitral valve MV and is slidably attachedto an actuation wire or shaft 512 that extends through the coaptionelement 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500includes barbed portions 800 arranged on the inner paddles 522, witheach inner paddle 522 optionally having more than one barbed portion800. When the anchor portion 506 of the device 500 is closed, tissuegrasped between the inner paddles 522 and the coaption element 510 ispressed against the barbed portions 800. The barbed portions 800 aresharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800 are angled downward toincrease engagement with the native tissue.

Referring now to FIG. 86A, the exemplary implantable device 500A isshown that does not include articulable clasps or gripping elements. Asdescribed above, the device 500A a coaption element 510A that is adaptedto be implanted between the leaflets 20, 22 of the native mitral valveMV and is slidably attached to an actuation wire or shaft (not shown)that extends through the coaption element 510A to a distal cap 514A. Thedevice 500A also includes outer paddles 520A and inner paddles 522A thatare connected between the distal cap 514A and the coaption element 510A.The device 500A is actuatable between open and closed conditions and cantake a wide variety of forms, such as, for example, paddles, grippingelements, or the like. Actuation of the actuation wire opens and closesthe paddles 520A, 522A of the device 500A to grasp the mitral valveleaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500Aincludes barbed portions 800A arranged on the inner paddles 522A, witheach inner paddle 522A optionally having more than one barbed portion800A. When the device 500A is closed, tissue grasped between the innerpaddles 522A and the coaption element 510A is pressed against the barbedportions 800A. The barbed portions 800A are sharp so that theyengage—and in some embodiments, pierce—the native tissue and prohibitthe tissue from retracting from the device 500A. In some embodiments,the barbed portions 800A are angled downward to increase engagement withthe native tissue.

Referring now to FIG. 87, the exemplary implantable device 500 is shownthat does not include separate articulable clasps or gripping elements.As described above, the device 500 includes a coaption portion 502 andan anchor portion 504. The coaption portion 502 of the device 500includes a coaption element 510 that is adapted to be implanted betweenthe leaflets 20, 22 of the native mitral valve MV and is slidablyattached to an actuation wire or shaft 512 that extends through thecoaption element 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than separate articulable clasps or gripping elements, the device500 includes barbed portions 800 arranged on the coaption element 510,with each side of the coaption element 510 having more than one barbedportion 800. When the anchor portion 506 of the device 500 is closed,tissue grasped between the inner paddles 522 and the coaption element510 is pressed against the barbed portions 800. The barbed portions 800are sharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800 are angled downward toincrease engagement with the native tissue.

Referring now to FIG. 87A, the exemplary implantable device 500A isshown that does not include articulable clasps or gripping elements. Asdescribed above, the device 500A can have a coaption element 510A thatis adapted to be implanted between the leaflets 20, 22 of the nativemitral valve MV and is slidably attached to an actuation wire or shaft(not shown) that extends through the coaption element 510A to a distalcap 514A. The device 500A also includes outer paddles 520A and innerpaddles 522A that are connected between the distal cap 514A and thecoaption element 510A. The device 500A is actuatable between open andclosed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire opens and closes the paddles 520A, 522A of the device500A to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than separate articulable clasps or gripping elements, the device500A includes barbed portions 800A arranged on the coaption element510A, with each side of the coaption element 510A having more than onebarbed portion 800A. When the device 500A is closed, tissue graspedbetween the inner paddles 522A and the coaption element 510A is pressedagainst the barbed portions 800A. The barbed portions 800A are sharp sothat they engage—and in some embodiments, pierce—the native tissue andprohibit the tissue from retracting from the device 500A. In someembodiments, the barbed portions 800A are angled downward to increaseengagement with the native tissue.

Referring now to FIG. 88, the exemplary implantable device 500 is shownthat does not include separate articulable clasps or gripping elements.As described above, the device 500 includes a coaption portion 502 andan anchor portion 504. The coaption portion 502 of the device 500includes a coaption element 510 that is adapted to be implanted betweenthe leaflets 20, 22 of the native mitral valve MV and is slidablyattached to an actuation wire or shaft 512 that extends through thecoaption element 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500includes barbed portions 800 arranged on the coaption element 510, witheach side of the coaption element 510 including at least one barbedportion 800. Similar to device 1500 described above, the device 500 alsoincludes barbed portions 802 arranged on the inner paddles 522, witheach inner paddle 522 having at least one barbed portion 802.

When the anchor portion 506 of the device 500 is closed, tissue graspedbetween the inner paddles 522 and the coaption element 510 is pressedagainst the barbed portions 800, 802. The barbed portions 800, 802 aresharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800, 802 are angled downward toincrease engagement with the native tissue. The combination of barbedportions 800 on the coaption element 510 and barbed portions 802 on theinner paddles 522 forms the grasped tissue into an S-shaped tortuouspath as it passes over the barbed portions 800, 802. Thus, forcespulling the tissue away from the device 500 will encourage the tissue tofurther engage the barbed portions 800, 802 before the tissue canescape.

Referring now to FIG. 88A, the exemplary implantable device 500A isshown that does not include articulable clasps or gripping elements. Asdescribed above, the device 500A can have a coaption element 510A thatis adapted to be implanted between the leaflets 20, 22 of the nativemitral valve MV and is slidably attached to an actuation wire or shaft(not shown) that extends through the coaption element 510A to a distalcap 514A. The device 500A also includes outer paddles 520A and innerpaddles 522A that are connected between the distal cap 514A and thecoaption element 510A. The device 500A is actuatable between open andclosed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire opens and closes the paddles 520A, 522A of the device500A to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500Aincludes barbed portions 800A arranged on the coaption element 510A,with each side of the coaption element 510A including at least onebarbed portion 800A. The device 500A also includes barbed portions 802Aarranged on the inner paddles 522A, with each inner paddle 522A havingat least one barbed portion 802A.

When the device 500A is closed, tissue grasped between the inner paddles522A and the coaption element 510A is pressed against the barbedportions 800A, 802A. The barbed portions 800A, 802A are sharp so thatthey engage—and in some embodiments, pierce—the native tissue andprohibit the tissue from retracting from the device 500A. In someembodiments, the barbed portions 800A, 802A are angled downward toincrease engagement with the native tissue. The combination of barbedportions 800A on the coaption element 510A and barbed portions 802A onthe inner paddles 522A forms the grasped tissue into an S-shapedtortuous path as it passes over the barbed portions 800A, 802A. Thus,forces pulling the tissue away from the device 500A will encourage thetissue to further engage the barbed portions 800A, 802A before thetissue can escape.

Referring now to FIGS. 89-102, the coaption element 510 and paddles 520,522 of the exemplary device 500 are shown. The coaption element 510 andthe paddles can be made from a wide variety of different materials. Thecoaption element 510 and paddles 520,522 may be formed from a materialthat may be a metal fabric, such as a mesh, woven, braided, electrospunor formed in any other suitable way or a laser cut or otherwise cutflexible material. The material may be cloth, shape-memory alloywire—such as Nitinol—to provide shape-setting capability, or any otherflexible material suitable for implantation in the human body.

In one exemplary embodiment, the coaption element is made from a braidedmesh of metal wires, such as a braided mesh of nitinol wires. In oneexemplary embodiment, the coaption element 510 is made of a braided meshof between 25 and 100 wires, such as between 40 and 85 wires, such asbetween 45 and 60 wires, such as about 48 Nitinol wires or 48 Nitinolwires.

The coaption element can be covered in a cloth, such as a polyethylenecloth. The coaption element 510 can be surrounded in its entirety with acloth cover, such as a polyethylene cloth of a fine mesh. The clothcover can provide a blood seal on the surface of the spacer, and/orpromote rapid tissue ingrowth.

The use of a shape memory material, such as braided Nitinol wire mesh,for the construction of the coaption element 510 results in a coaptionelement that can self-expandable, flexible in all directions, and/orresults in low strains when the coaption element is crimped and/or bent.The material can be a single piece, two halves joined together, or aplurality of sections or pieces that are fastened or joined together inany suitable manner, such as, by welding, with adhesives, or the like.

Referring now to FIGS. 89-90, the device 500 extends from a proximalportion 505 to a distal portion 507 and includes a coaption element 510,inner paddles 522, and outer paddles 520. The coaption element 510includes a proximal opening 519A and a distal opening 515 (FIGS. 92 and94). The proximal opening 519A of the coaption element 510 is formed ina proximal portion 519 of the coaption element 510. The coaption element510 is jointably connected to the inner paddles 522 by joint portions525. The inner paddles 522 are jointably connected to the outer paddles520 by joint portions 523. The outer paddles 520 are jointably attachedto distal portions 527 by joint portions 521. Coaption gaps 542 areformed between the inner paddles 522 and the coaption element 510.Paddle gaps 544 are formed between the inner and outer paddles 520, 522when the paddles 520, 522 are folded, for example, as shown in FIG. 90.

Referring now to FIG. 91, a front view of the device 500 is shown (aback view of which would be identical). The coaption element 510includes the proximal portion 519, a middle portion 518, and a distalportion 517. The proximal portion 519 includes the proximal opening519A. The distal portion 517 includes the distal opening 515 and isconnected to the joint portions 525. The shape of the coaption element510 is generally rounded to prevent the device 500 from catching orsnagging on structures of the heart, such as the chordae tendineae,during implantation.

Referring now to FIG. 92, a side view of the device 500 is shown.Similar to the device 500 viewed from the front, the distal portion 507of the device 500 is generally narrower than the proximal portion 505 ofthe device 500 when the device 500 is viewed from the side. The coaptionelement 510 flares outwards in the proximal portion 519 from theproximal opening 519A to the middle portion 518. The coaption element510 then tapers or narrows in the middle portion 518 from the proximalportion 519 to the distal portion 517. The distal portion 517 remainsnarrow and then splits into the two joint portions 525. The generallyrounded features of the device 500 are further demonstrated by the roundshape of the joint portions 523 that jointably connect the inner andouter paddles 520, 522 and the outwardly bowed shape of the outerpaddles 520.

The coaption gaps 542 formed between the inner paddles 522 and thecoaption element 510 are configured to receive native tissue. Thenarrowing of the coaption element 510 gives the gaps 542 a somewhatteardrop shape that increases in width as the gaps 542 approach thedistal portion 507 of the device 500. The widening of the gaps 542toward the distal portion 507 allows the inner paddles 522 to contacttissue grasped in the gaps 542 nearer to the proximal portion 505 wherepinching forces are greater as a result of the mechanical advantageprovided by the length of the paddles 520, 522 and other securing oranchoring elements, such as those described in the present application.

Referring now to FIG. 93, a top view of the device 500 is shown. Theproximal opening 519A in the coaption element 510 is visible at theproximal portion 505 of the device 500 and the coaption element 510 canbe seen to be hollow inside. The coaption element 510 has a generallyoval-shape when viewed from the top. While the paddles 520, 522 appearas protruding rectangular shapes, the paddles 520, 522 can extendlaterally and have an arcuate or crescent-like shape.

Referring now to FIG. 94, a bottom view of the device 500 is shown. Thedistal opening 515 in the coaption element 510 is visible at the distalportion 507 of the device 500 and the coaption element 510 can be seento be hollow inside. The coaption element 510 has a generally oval-shapewhen viewed from the top. While the paddles 520, 522 appear asprotruding rectangular shapes, the paddles 520, 522 can extend laterallyand have an arcuate or crescent-like shape. The distal portion 517 ofthe coaption element 510 can be seen splitting in two to join with thejoint portions 525.

Referring now to FIGS. 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A,99A, 100A, 101A, and 102A, the portions of the device 500A formed by thesingle, continuous strip of material 501A, that is, the coaption element510A and paddles 520A, 522A, are shown. The coaption element 510A andthe paddles can be made from a wide variety of different materials. Thecoaption element 510A, and paddles 520A, 522A may be formed from amaterial that may be a metal fabric, such as a mesh, woven, braided,electrospun or formed in any other suitable way or a laser cut orotherwise cut flexible material. The material may be cloth, shape-memoryalloy wire—such as Nitinol—to provide shape-setting capability, or anyother flexible material suitable for implantation in the human body.

In one exemplary embodiment, the coaption element 510A, inner paddle522A, and outer paddle 520A are made from a single, continuous strip ofmaterial 501A. The strip of material 501A may be formed from a materialthat may be a metal fabric, such as a mesh, woven, braided, electrospunor formed in any other suitable way or a laser cut or otherwise cutflexible material. The material may be cloth, shape-memory alloywire—such as Nitinol—to provide shape-setting capability, or any otherflexible material suitable for implantation in the human body. In oneexemplary embodiment, the strip of material 501A is made of a braidedmesh of between 25 and 100 strands, such as between 40 and 85 strands,such as between 45 and 60 strands, such as about 48 Nitinol wires or 48Nitinol wires.

Referring now to FIGS. 205-207, an exemplary woven or braided material4000 that may be used for the strip of material 501A is shown. Referringnow to FIG. 205, an enlarged plan view of the material 4000 is shown.The material 4000 extends from a first edge 4002 to a second edge 4004.The edges 4002, 4004 surround a central portion or field 4006. Thematerial 4000 is formed by braiding or weaving together central strands4020, such as Nitinol wires. Edge strands 4010 extend longitudinallythrough the material 4000 along the edges 4002, 4004. The centralstrands 4020 are woven or braided such that the central strands 4020wrap around the edge strands 4010. Wrapping the central strands 4020around the edge strands 4010 causes the material 4000 near the edges4002, 4004 to be thicker than the material in the central portion 4006,forming a lobed or dog-bone-like shape when the material 4000 is viewedfrom the end, as is shown in FIG. 206. Thus, the edges 4002, 4004 of thematerial 4000 are less flexible than the central portion 4006. The edgestrands 4010 and central strands 4020 can be similar in diameter and canhave a diameter ranging from about 0.06 millimeters to about 0.18millimeters. In some embodiments, the edge strands 4010 may have alarger diameter than the central strands 4020 to impart more stiffnessor rigidity to the edges 4002, 4004 than the central portion 4006. Forexample, the edge strands 4010 can have a diameter ranging from 0.07millimeters to about 0.27 millimeters, or about 0.17 millimeters, andthe central strands 4020 can have a diameter ranging from about 0.04millimeters to about 0.15 millimeters, or about 0.009 millimeters. Insome embodiments, the edges 4002, 4004 are made less flexible than thecentral portion 4006 by using different materials for the edge strands4010 and central strands 4020, such as, for example, a metalmaterial—e.g., Nitinol—for the edge strands 4010 and a cloth or plasticmaterial—e.g., polyethylene—for the central strands 4020. Alternatively,the edge strands 4010 and central strands 4020 may be made from the samematerial that is subjected to different chemical and or thermalprocesses that alter the flexibility of the materials so that thecentral strands 4020 are more flexible than the edge strands 4010.

Referring now to FIG. 207, folded portions of material 4000 are layeredon top of each other to form a section that has four layers 4000A,4000B, 4000C, 4000D. The lobed shape of the individual layers, withthicker edges 4002, 4004 than the central portion 4006, creates threegaps 4001A, 4001B, 4001C between the layers 4000A, 4000B, 4000C, 4000Dof material 4000 in the location of the central portion 4006. Outer gaps4001A, 4001C are formed between outer layers 4000A, 4000D and theadjacent middle layers 4000B, 4000C.

As is discussed in the present disclosure, the coaption element 510A ofthe device 500A can be formed from four layers of material, such as thematerial 4000. When layers of the material 4000 are used to form thecoaption element 510A, the actuation wire 512A of the device 500A can beinserted through the middle gap 4001B formed in the center of the fourlayers of material 4000. The actuation wire 512A may have a largerdiameter than the width of the gap 4001B, so that inserting theactuation wire 512A causes the middle gap 4001B to stretch open andadjacent outer gaps 4001A, 4001C to reduce in size. In some embodiments,inserting the actuation wire 512A causes the center body portions 4006on either side to bulge outward to a thickness that is greater than thethickness of the four stacked edge portions 4002, 4004.

The coaption element 510A and paddles 520A, 522A can be covered in acloth, such as a polyethylene cloth. The coaption element 510A andpaddles 520A, 522A can be surrounded in their entirety with a clothcover (e.g., cover 540A), such as a polyethylene cloth of a fine mesh.The cloth cover can provide a blood seal on the surface of the spacer,and/or promote rapid tissue ingrowth.

The use of a shape memory material, such as braided Nitinol wire mesh,for the construction of the coaption element 510A and paddles 520A, 522Aresults in a coaption element and paddles that can be self-expandable,flexible in all directions, and/or results in low strains when crimpedand/or bent. The material can be a single piece, two halves joinedtogether, or a plurality of sections or pieces that are fastened orjoined together in any suitable manner, such as, by welding, withadhesives, or the like.

Referring now to FIGS. 89A and 90A, the device 500A extends from aproximal portion 505A to a distal portion 507A and includes a coaptionelement 510A, inner paddles 522A, and outer paddles 520A. The single,continuous strip of material 501A extends between two ends 501B and isfolded to form the coaption element 510A, inner paddles 522A, and outerpaddles 520A. Some portions of the device 500A are formed from multiplelayers of the strip of material 501A. For example, the strip of material501A is overlapped to form four layers in the area of the coaptionelement 510A and two layers in the area of the inner paddle 522A.

The coaption element 510A and paddles 520A, 522A are jointably connectedtogether by joint portions of the strip of material 501A. The coaptionelement 510A is jointably connected to the inner paddles 522A by jointportions 525A. The inner paddles 522A are jointably connected to theouter paddles 520A by joint portions 523A. The outer paddles 520A arejointably attached to the distal portion 527A by joint portions 521A.The aperture 527B in the distal portion 527A engages the cap 514A.

Various gaps are formed between portions of the device 500A when thestrip of material 501A is folded into the desired shape. Coaption gaps542A are formed between the inner paddles 522A and the coaption element510A. Paddle gaps 544A are formed between the inner and outer paddles520A, 522A when the paddles 520A, 522A are folded, for example, as shownin FIG. 90A. Collar gaps 546A are formed when the strip of material 501Ais folded to form the proximal portions 519B of the coaption element510A.

Referring now to FIG. 91A, a front view of the device 500A is shown (aback view of which would be identical). The coaption element 510Aincludes the proximal portion 519B extending above the joint portions523A of the paddles 520A, 522A. The distal portion 517A of the coaptionelement 510A is concealed by the paddles 520A, 522A when viewed from thefront or back, giving the device 500A a long and narrow roundedrectangular shape. The shape of the coaption element 510A helps preventthe device 500A from catching or snagging on structures of the heart,such as the chordae tendineae, during implantation.

Referring now to FIG. 92A, a side view of the device 500A is shown. Thedistal end 507A of the device 500A is generally narrower than theproximal end 505A of the device 500A when the device 500A is viewed fromthe side, forming a generally blunt and rounded shape. The coaptionelement 510A includes the proximal portion 519B, a middle portion 518A,and the distal portion 517A. The proximal portion 519B flares outwardfrom the middle portion 518A to engage the collar 511D (FIG. 48A). Themiddle portion 518A of the coaption element 510A is generally straightwhen viewed from the side. The distal portion 517A is jointably attachedto the inner paddles 522A by the joint portions 525A. The generallyrounded features of the device 500A are further demonstrated by theround shape of the joint portions 523A that jointably connect thepaddles 520A, 522A. The joint portions 521A connecting the outer paddles520A to the distal portion 527A are also rounded and ease the transitionin shape from the strip of material 501A to the cap 514A (FIG. 48A) thatis assembled to the generally flat distal portion 527A.

The coaption gaps 542A formed between the inner paddles 522A and thecoaption element 510A are configured to receive native tissue. Thegeneral straightness of the middle portion 518A of the coaption element510A and the inner paddles 522A gives the gaps 542A a generallyconsistent width with a narrow upper end where the proximal portion 519Bflares outward to engage the collar 511D (FIG. 48A). Thus, the innerpaddles 522A contact the tissue grasped in the gaps 542A nearer to theproximal portion 505A where pinching forces are greater as a result ofthe mechanical advantage provided by the length of the paddles 520A,522A and other securing or anchoring elements, such as those describedin the present application.

As discussed above, the coaption element 510A and paddles 520A, 522A ofthe device 500A are formed by folding the strip of material 501A. Thestrip of material 501A is then unfolded and assembled with othercomponents, such as the collar 511D, cap 514A, and paddle frames 524A.The strip of material 501A is shape-set after being formed into adesired shape so that the strip of material 501A returns to the desiredshape after assembly with other components. In some embodiments, a jigis used during folding and shape-setting of the strip of material 501Ato ensure that the strip of material 501A is folded in the properlocation with the desired radius.

Referring again to FIG. 92A, portions of a jig 570A to aid in foldingand shape-setting the device 500A are shown. The strip of material 501Ais shown folded around the jig 570A so that the strip of material 501Aforms a desired shape. To fold the strip of material 501A into the shapeof the device 500A using the jig 570A, the strip of material 501A isarranged with one of the ends 501B at the location of the inner paddle522A. The strip 501A is extended from the end 501B in a distal direction507B to form a first layer 581A of the inner paddle 522A, around a firstjig portion 572A to form a first layer 581A of the hinge portion 525A,and then in a proximal direction 505B to form the first layer 581A ofthe coaption element 510A. The first layer 581A of material forms thesides of the inner paddle 522A and coaption element 510A that surroundthe coaption gap 542A. The strip 501A is then wrapped around a secondjig portion 574A to form one of the proximal portions 519B and openings546A of the coaption element 510A. The strip 501A is then extended in adistal direction 507A along the first layer 581A to form a second layer582A of the coaption element 510A. The strip 501A is then wrapped backround the first jig portion 574A, forming the second layer 582A of thehinge portion 525A and back in the proximal direction 505A to form thesecond layer 582A of the inner paddle 522A. The strip 501A is thenwrapped around a third jig portion 576A to form the joint portion 523A.The strip 501A then extends in the distal direction 507A along the innerpaddle 522A to form the outer paddle 520A before being folded around afourth jig portion 578A to form the joint portion 521. The strip 501A isthen extended laterally to form the distal portion 527. The routing ofthe strip 501A through the jig 570A is then performed in reverse orderon the opposite side of the jig 570A to form the second half of thedevice 500A. That is, the strip 501A is then wrapped around the fourth,third, first, second, and first jig portions 578A, 576A, 572A, 574A,572A to form the second half of the device 500A. Once the strip 501A hasbeen wrapped around the jig portions as described above, a shape-settingoperation is performed. While the portions of the illustrated jig have agenerally round shape, the portions can have any shape to aid in thefolding and shaping of the strip of material 501A. The jig 570 may havemore or fewer portions for engaging the strip of material 501A.

Referring now to FIG. 93A, a top view of the device 500A is shown. Thefirst and second layers 581A, 582A of each half of the device 500A formthe four layers of the coaption device 510A. The proximal opening 519Cof the coaption device 510A is formed between the two second layers582A. In some embodiments, the opening 519C is formed by inserting theactuation wire 512A (not shown) between the folded and overlappinglayers of the strip of material 501A after shape-setting of the strip ofmaterial 501A. In other embodiments, the opening 519C is formed byshape-setting the folded layers 581A, 582A of the strip of material 501Aaround an additional jig portion (not shown) to give the coaptionelement 510A a generally rounded shape when viewed from the top.

Referring now to FIG. 94A, a bottom view of the device 500A is shown.The distal portion 527A of the strip of material 501A is shown, as isthe aperture 527B for receiving the cap 514A. The coaption element 510Aand outer paddles 520A have a generally rounded rectangle shape whenviewed from below.

Referring now to FIGS. 95-102, perspective and cross-sectional views ofthe device 500 are shown. Referring now to FIG. 95, the device 500 isshown sliced by cross-section plane 96 near the proximal portion of thecoaption element 510. Referring now to FIG. 96, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 96 in FIG.95. At the location of the plane 96, the coaption element 510 has agenerally oval shape with thicker portions along the sides of thecoaption element 510. The distal opening 515 is visible from theproximal portion and the coaption element 510 has a hollow interior.

Referring now to FIG. 97, the device 500 is shown sliced bycross-section plane 98 positioned about half of the way between thedistal portion 507 and the proximal portion 505 of the coaption element510. Referring now to FIG. 98, a cross-sectional view of the device 500is shown as viewed from cross-section plane 98 in FIG. 97. At thelocation of the plane 98, the coaption element 510 has a generally ovalshape that is larger than the oval shape of FIG. 96.

Referring now to FIG. 99, the device 500 is shown sliced bycross-section plane 100 positioned about one-quarter of the way betweenthe distal portion 507 and the proximal portion 505 of the coaptionelement 510. Referring now to FIG. 99, a cross-sectional view of thedevice 500 is shown as viewed from cross-section plane 100 in FIG. 99.At the location of the plane 100, the coaption element 510 has agenerally oval shape that is narrower than the oval shape seen in FIG.98.

Referring now to FIG. 101, the device 500 is shown sliced bycross-section plane 102 positioned near the distal portion 507 of thecoaption element 510. Referring now to FIG. 102, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 102 inFIG. 101. At the location of the plane 102, the coaption element 510 hasa generally oval shape that is smaller than the oval shape seen in FIG.100 and that is split as the coaption element 510 joins the jointportions 525.

Referring now to FIGS. 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A,perspective and cross-sectional views of the portions of the device 500Aformed by the single, continuous strip of material 501A are shown.Referring now to FIG. 95A, the device 500A is shown sliced bycross-section plane 96A near the proximal portion of the coaptionelement 510A. Referring now to FIG. 96A, a cross-sectional view of thedevice 500A is shown as viewed from cross-section plane 96A in FIG. 95A.At the location of the plane 96A, the coaption element 510 has agenerally rectangular shape. In some embodiments, when the actuationwire (not shown) is inserted between the layers 582A of the coaptionelement 510A, the coaption element 510A remains straight when viewedfrom the side but bows outward to form a generally round shape whenviewed from cross-section plane 96A.

Referring now to FIG. 97A, the device 500A is shown sliced bycross-section plane 98A near the proximal portion of the coaptionelement 510A. Referring now to FIG. 98A, a cross-sectional view of thedevice 500A is shown as viewed from cross-section plane 98A in FIG. 97A.At the location of the plane 98A, the coaption element 510 has agenerally rectangular shape. In some embodiments, when the actuationwire (not shown) is inserted between the layers 582A of the coaptionelement 510A, the coaption element 510A remains straight when viewedfrom the side but bows outward to form a generally round shape whenviewed from cross-section plane 98A.

Referring now to FIG. 99A, the device 500A is shown sliced bycross-section plane 100A near the proximal portion of the coaptionelement 510A. Referring now to FIG. 100A, a cross-sectional view of thedevice 500A is shown as viewed from cross-section plane 100A in FIG.99A. At the location of the plane 100A, the coaption element 510 has agenerally rectangular shape. In some embodiments, when the actuationwire (not shown) is inserted between the layers 582A of the coaptionelement 510A, the coaption element 510A remains straight when viewedfrom the side but bows outward to form a generally round shape whenviewed from cross-section plane 100A.

Referring now to FIG. 101A, the device 500A is shown sliced bycross-section plane 102A near the proximal portion of the coaptionelement 510A. Referring now to FIG. 102A, a cross-sectional view of thedevice 500A is shown as viewed from cross-section plane 102A in FIG.101A. At the location of the plane 102A, the coaption element 510 has agenerally rectangular shape. In some embodiments, when the actuationwire (not shown) is inserted between the layers 582A of the coaptionelement 510A, the coaption element 510A remains straight when viewedfrom the side but bows outward to form a generally round shape whenviewed from cross-section plane 102A.

Referring now to FIGS. 103-105, the exemplary implantable prostheticdevice 100 is shown having covered and uncovered portions. The device100 is shown implanted in the native mitral valve MV and secured to thenative leaflets 20, 22. As described above, the device 100 includes acoaption element or means for coapting 110, paddles 120, clasps 130, anda cap 114. The paddles 120 and clasps 130 are in a closed position tosecure the device 100 to the grasped native leaflets 20, 22 of themitral valve MV. A proximal portion 105 of the device 100 is exposed tothe left atrium LA and a distal portion 107 of the device 100 is exposedto the left ventricle LV.

Referring now to FIG. 103, the device 100 is shown with a covering 900that covers the entirety of the coaption element or means for coapting110 and the cap 114. In some embodiments, the covering 900 can be acloth or fabric such as PET, velour, electrospun or other suitablefabric. In other embodiments, in lieu of or in addition to a fabric, thecover can include a coating (e.g., polymeric) that is applied to theprosthetic spacer device and/or mechanical sealing mechanisms, such assilicone and interlocking joints can be used. The covering 900 can beformed from a metal fabric, such as a mesh, woven, braided, or formed inany other suitable way or a laser cut or otherwise cut flexiblematerial. The covering 900 may be cloth, shape-memory alloy wire—such asNitinol—to provide shape-setting capability, or any other flexiblematerial suitable for implantation in the human body. The covering 900prohibits blood flow through coaption element or means for coapting 110at the proximal portion 105, and also provides a seal between the device100 and the leaflets 20, 22. Thus, the covering 900 aids in theprohibition of blood flow through the mitral valve MV at the location ofthe device 100. The covering 900 also prohibits recirculating blood flowfrom entering the device 100 from the distal portion 107.

Referring now to FIG. 104, the device 100 is shown with a covering 1000that partially covers the coaption element or means for coapting 110from the proximal portion 105 of the device 100 to the portion of thecoaption element or means for coapting 110 that engages the nativeleaflets 20, 22. In some embodiments, the cover can be a cloth or fabricsuch as PET, velour, or other suitable fabric. In other embodiments, inlieu of or in addition to a fabric, the cover can include a coating(e.g., polymeric) that is applied to the prosthetic spacer device. Thecovering 1000 can be formed from a metal fabric, such as a mesh, woven,braided, or formed in any other suitable way or a laser cut or otherwisecut flexible material. The covering 1000 may be cloth, shape-memoryalloy wire—such as Nitinol—to provide shape-setting capability, or anyother flexible material suitable for implantation in the human body.Thus, the covering 1000 prohibits blood flow through the coaptionelement or means for coapting 110 at the proximal portion 105.

Referring now to FIG. 105, the device 100 is shown with a covering 1100that partially covers the coaption element or means for coapting 110extending from the portion of the coaption element or means for coapting110 that engages the native leaflets 20, 22 toward the distal portion107. The covering 1100 also covers the cap 114. In some embodiments, thecover can be a cloth or fabric such as PET, velour, or other suitablefabric. In other embodiments, in lieu of or in addition to a fabric, thecover can include a coating (e.g., polymeric) that is applied to theprosthetic spacer device. The covering 1100 can be formed from a mesh,woven, braided, or formed in any other suitable way. The covering 1100may be cloth, electrospun material, and/or shape-memory alloy wire—suchas Nitinol—to provide shape-setting capability, or any other flexiblematerial suitable for implantation in the human body. Thus, blood flowcan enter the coaption element or means for coapting 110 but isprohibited from passing through the device by the covering 1100 arrangedtoward the distal portion 107. The covering 1100 also prohibitsrecirculating blood flow from entering the device 100 from the distalportion 107.

Referring now to FIGS. 106-109, an exemplary coaption element 1200 foran implantable prosthetic device is shown. The coaption element 1200 canbe used with any of the implantable prosthetic devices described in thepresent application. Referring to FIG. 106, the coaption element 1200has a generally cylindrical shape extending between two caps 1201.However, the coaption element 1200 can have any shape, such as any ofthe shapes disclosed herein. In one exemplary embodiment, the directionof expansion of the coaption element 1200 can be controlled. Forexample, the width/size of the coaption element in the Anterior toPosterior direction (when implanted), Medial to Lateral direction (whenimplanted), or both can be expanded (or contracted) in a controlledmanner. The coaption element can be made from a mesh 1200 of material.Referring now to FIG. 107, the mesh wall of the generally cylindricalcoaption element 1200 extends outward from the caps 1201 by a distance1204. Referring now to FIG. 108, axial forces 1208 are applied to thecaps 1201 of the coaption element 1200 causing the coaption element 1200to compress in an axial direction. Compressing the coaption element 1200axially causes the coaption element 1200 to expand or bulge in anoutward direction 1210, such that the distance 1204 increases.

The coaption element 1200 can be compressed in a wide variety ofdifferent ways. For example, a threaded connection can be used to drawthe two ends of the coaption element together or push the two ends ofthe coaption element apart. For example, a collar can be provided oneach end of the coaption element. One of the collars can threadedlyengage a threaded shaft, while the other collar is rotatably connectedto the shaft. Rotating the shaft in one direction draws the collarstogether. Rotating the shaft in the opposite direction moves the collarsapart.

Incorporating the coaption element 1200 into an implantable prostheticdevice of the present application allows the coaption element to beexpanded to press outward against tissue grasped between the coaptionelement and the paddles and/or gripping members.

Referring now to FIGS. 106A, 108A, 106B, and 108B, exemplary coaptionelements 1200, similar to the embodiment illustrated by FIGS. 106-109,for an implantable prosthetic device is shown. The coaption element 1200can be used with any of the implantable prosthetic devices described inthe present application. Referring to FIG. 106A, the coaption element1200 has a generally cylindrical shape extending between two caps 1201.However, the coaption element 1200 can have any shape, such as any ofthe shapes disclosed herein. In the example illustrated by FIGS. 106Aand 108A, the coaption element 1200 comprises a tube 1203 with slots1205. For example, the tube 1203 can be made from a shape memory alloy,such as nitinol, and the slots can be cut, such as laser cut, into thetube. The slots can be cut into the material that forms the tube, beforethe material is formed into a tube.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, the configuration of theslots 1205 and/or a shape-set of the tube can be selected to control theshape of the expanded coaption element 1200. For example, theconfiguration of the slots 1205 and/or a shape-set can determine the waythe width/size of the coaption element in the Anterior to Posteriordirection, and/or Medial to Lateral direction expanded (and/orcontract). Referring to FIG. 106A, the tube wall of the generallycylindrical coaption element 1200 can extend outward from caps 1201 by adistance 1204. Referring now to FIG. 108A, axial forces 1208 and/orrotational forces 1209 can be applied to the caps 1201 of the coaptionelement 1200 causing the coaption element 1200 to expand from theconfiguration illustrated by FIG. 106A to the configuration illustratedby FIG. 108A. In the illustrated example, compressing the coaptionelement 1200 axially and twisting the coaption element the coaptionelement 1200 to expand or bulge in an outward direction 1210, such thatthe distance 1204 increases.

Referring to FIGS. 106B and 108B, the coaption element 1200 can becompressed in a wide variety of different ways. For example, a threadedconnection 1221 can be used to draw the two ends of the coaption elementtogether and twist the coaption element in a first direction or push thetwo ends of the coaption element apart and twist the coaption element ina second direction. For example, a collar can be provided on each end ofthe coaption element. One of the collars can threadedly engage athreaded shaft, while the other collar is fixedly connected to theshaft. Rotating the shaft in one direction draws the collars togetherand rotates the collars relative to one another in a first direction.Rotating the shaft in the opposite direction moves the collars apart androtates the collars relative to one another in a second direction. Thepitch of the threaded connection can be selected to set a ratio betweenthe distance the coaption element 1200 is compressed and the angle thatthe coaption element is twisted.

Incorporating the coaption elements 1200 illustrated by FIGS. 106A,108A, 106B, and 108B into an implantable prosthetic device of thepresent application allows the coaption element to be expanded to pressoutward against tissue grasped between the coaption element and thepaddles and/or gripping members.

FIGS. 106C and 108C illustrate another exemplary embodiment of acontrollably expandable coaption element 1200 for an implantableprosthetic device. The coaption element 1200 can be used on its own,with a covering, or inside any of the coaption elements described herein(to expand the coaption element). The coaption element 1200 can be usedwith any of the implantable prosthetic devices described in the presentapplication. Referring to FIG. 106C, the coaption element 1200 has pairsof pivotally connected arms 1231. The pairs of pivotally connected arms1231 each extending between and pivotally connected to two caps 1201. Inthe illustrated example, there are two pairs of pivotally connected arms1231. However, there can be one, three, four, or any number of pairs ofpivotally connected arms.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, two pairs (as illustrated)of pivotally connected arms can be included to change the width/size ofthe coaption element in only one of the Anterior to Posterior direction,and/or Medial to Lateral direction. Four pairs of pivotally connectedarms 1231 can be included to change the width/size of the coaptionelement in both the Anterior to Posterior direction and Medial toLateral direction. When four pairs of pivotally connected arms 1231 areincluded, the arms may have different lengths and/or pivot pointlocations to make the coaption element 1200 expand (or contract)differently in different dictions. For example, the lengths of the armscan be selected to expand more in the Medial to Lateral direction thanthe Anterior to Posterior direction.

Referring now to FIG. 108C, axial forces 1208 can be applied to the caps1201 of the coaption element 1200 causing the coaption element 1200 toexpand from the configuration illustrated by FIG. 106C to theconfiguration illustrated by FIG. 108C. In the illustrated example,compressing the pivotally connected arms 1231 axially causes the pivotalconnections 1233 or knees to spread apart in an outward direction 1210,such that the distance 1204 increases.

Referring to FIGS. 106C and 108C, the coaption element 1200 can becompressed in a wide variety of different ways. For example, a threadedconnection 1221 can be used to draw the two ends of the coaption elementtogether or push the two ends of the coaption element apart. Forexample, a collar can be provided on each end of the coaption element.One of the collars can threadedly engage a threaded shaft, while theother collar is rotatably connected to the shaft. Rotating the shaft inone direction draws the collars together. Rotating the shaft in theopposite direction moves the collars apart.

Incorporating the coaption element 1200 illustrated by FIGS. 106C, and108C into an implantable prosthetic device of the present applicationallows the coaption element to be expanded to press outward againsttissue grasped between the coaption element and the paddles and/orgripping members.

FIGS. 106D and 108D illustrate another exemplary embodiment of anexpandable coaption element 1200 for an implantable prosthetic device.The coaption element 1200 can be used on its own, with a covering (SeeFIGS. 106E and 108E), or inside any of the coaption elements describedherein (to expand the coaption element). The coaption element 1200 canbe used with any of the implantable prosthetic devices described in thepresent application. Referring to FIG. 106C, the coaption element 1200has, a central support member 1243, one or more pivotally connected arms1241, and connection lines 1245. Each arm 1241 extends from a pivotalconnection to the central support member 1243. Each connection line 1245is connected to the central support member 1243 and a pivotallyconnected arm 1241. The length of the connection line 1245 sets thedegree to which the connection arms pivot away from the central supportmember 1243. In the illustrated example, there are two pivotallyconnected arms 1241. However, there can be one, three, four, or anynumber of pivotally connected arms.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, two pivotally connectedarms can be included to change the width/size of the coaption element inonly one of the Anterior to Posterior direction, and/or Medial toLateral direction. Four pivotally connected arms 1241 can be included tochange the width/size of the coaption element in both the Anterior toPosterior direction and Medial to Lateral direction. When four pivotallyconnected arms 1241 are included, the arms and/or the connection lines1245 may have different lengths and/or pivot point locations to make thecoaption element 1200 expand (or contract) differently in differentdictions. For example, the lengths of the arms and/or the connectionlines can be selected to expand more in the Medial to Lateral directionthan the Anterior to Posterior direction.

The arms 1241 can be moved from the contracted position (FIG. 106D) tothe expanded position (FIG. 108D). For example, the arms 1241 can bebiased toward the expanded position 1241 by a spring or other biasingmeans. In the illustrated example, restraints 1247, such as sutures holdthe arms 1241 in the contracted position. The restraints 1247 can beremoved or broken to cause the coaption element 1200 to expand from theconfiguration illustrated by FIG. 106D to the configuration illustratedby FIG. 108D.

FIGS. 106E and 108E illustrate an exemplary embodiment that is similarto the embodiment illustrated by FIGS. 106D and 108D, except that thecoaption element includes a covering material 1253. The coveringmaterial 1253 can extend from the central support member 1243 to eacharm 1241. The covering material 1253 can be used with the connectionlines 1245 or the covering material can eliminate the need for theconnection lines 1245.

Referring now to FIG. 106F, an exemplary coaption element 1200, similarto the embodiment illustrated by FIGS. 106-109, for an implantableprosthetic device is shown. The coaption element 1200 can be used withany of the implantable prosthetic devices described in the presentapplication. Referring to FIG. 106F, the coaption element 1200 isdefined by a coil 1263 extending between two caps 1201. The coaptionelement 1200 can have any shape, such as any of the shapes disclosedherein. The coil 1263 can be made from a shape memory alloy, such asnitinol.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, the shape-set of the coil1263 can be selected to control the shape of the expanded coaptionelement 1200. For example, the configuration of the shape-set candetermine the way the width/size of the coaption element in the Anteriorto Posterior direction, and/or Medial to Lateral direction expand(and/or contract). Referring to Axial forces 1208 and/or rotationalforces 1209 can be applied to caps 1201 of the coaption element 1200causing the coaption element 1200 to expand or retract from theconfiguration illustrated by FIG. 106F. In the illustrated example,extending the coil 1263 axially and twisting the coil 1263 contracts thecoil in an inward direction 1211 and compressing the coil 1263 axiallyand twisting the coil in the opposite direction expands or bulge thecoil in an outward direction.

Referring to FIG. 106F, the coaption element 1200 can be compressed in awide variety of different ways. For example, a threaded connection 1221can be used to draw the two ends of the coaption element together andtwist the coaption element in a first direction or push the two ends ofthe coaption element apart and twist the coaption element in a seconddirection. For example, a collar can be fixedly connected to each end ofthe coil 1263. One of the collars can threadedly engage a threadedshaft, while the other collar is fixedly connected to the shaft.Rotating the shaft in one direction draws the collars together androtates the collars relative to one another in a first direction.Rotating the shaft in the opposite direction moves the collars apart androtates the collars relative to one another in a second direction. Thepitch of the threaded connection can be selected to set a ratio betweenthe distance the coaption element 1200 is compressed and the angle thatthe coaption element is twisted.

Incorporating the coaption elements 1200 illustrated by FIG. 106F intoan implantable prosthetic device of the present application allows thecoaption element to be expanded to press outward against tissue graspedbetween the coaption element and the paddles and/or gripping members.

FIGS. 106G-106I illustrate exemplary embodiments of expandable coaptionelements 1200. In the examples illustrated by FIGS. 106G-106I, thecoaption elements are inflated by a fluid medium to expand the coaptionelement. The fluid medium can take a wide variety of different forms.Examples of fluids that can be used to inflate the coaption element 1200include, but are not limited to, air, gel, water, blood, foamingmaterials, etc. The coaption element 1200 can be used with any of theimplantable prosthetic devices described in the present application.

Referring to FIG. 106G, the coaption element 1200 can have an outerlayer 1271 (For example, any of the coaption elements 110, 510 disclosedherein) and an inner layer 1273 or balloon. The coaption element 1200can have any shape, such as any of the shapes disclosed herein. In theexample illustrated by FIGS. 106G and 1086, the inner layer 1273 isdisposed in the outer layer 1271 and can have generally the same shapeas the inner surface of the outer layer. The inner layer can be madefrom an expandable material, such as a rubber or other materialtraditionally used for making balloons and angioplasty devices. Theouter layer 1271 can be made from a shape memory alloy, such as nitinol.

Referring to FIGS. 106H and 106I, in one exemplary embodiment, thedirection of expansion of the coaption element 1200 can be controlled.In the example illustrated by FIG. 106H, the inner layer 1273 comprisestwo balloons that are optionally connected together. However, any numberof balloons can be used. For example, the inner layer can comprise 3, 4,or any number of balloons. The balloons can be individually inflated tocontrol the shape of expansion of the coaption element 1200. When theballoons are connected together, the connection can also affect theshape of expansion. In the example illustrated by 106H, the balloons areconnected together along a plane 1275 or area. Expansion of the innerlayer 1273 in the direction 1277 will be less than the expansion in thedirection 1279 due to the connection 1275. As such, in this example, theexpansion due to inflation can be limited to or substantially limited toexpansion in the Medial to Lateral direction.

The use of multiple balloons and the configuration of any connectionsbetween the balloons can determine the way the width/size of thecoaption element in the Anterior to Posterior direction, and/or Medialto Lateral direction expand (and/or contract).

In the example illustrated by FIG. 106I, the inner layer 1273 comprisesone or more supports 1281 or struts. One support 1281 is illustrated,but any number can be used. For example, the inner layer can comprise 2,3, 4, or any number of supports. The supports 1281 can divide the innerlayer into multiple independently inflatable chambers or the supportsmay not seal off independent chambers and inflation fluid applied to anychamber will fill all of the chambers. When there are independentlyinflatable chambers, the chambers can be individually inflated tocontrol the shape of expansion of the coaption element 1200. Thesupports also affect the shape of expansion. In the example illustratedby 1061, the support 1281 will reduce or eliminate expansion of theinner layer 1273 in the direction 1277. As such, in this example, theexpansion due to inflation can be limited to or substantially limited toexpansion in the Medial to Lateral direction.

The use of multiple independently inflatable chambers and/or theconfiguration of the support members 1281 can determine the way thewidth/size of the coaption element in the Anterior to Posteriordirection, and/or Medial to Lateral direction expand (and/or contract).

Incorporating the coaption elements 1200 illustrated by FIGS. 106G-106Iinto an implantable prosthetic device of the present application allowsthe coaption element to be expanded to press outward against tissuegrasped between the coaption element and the paddles and/or grippingmembers.

Referring now to FIGS. 110-111, an exemplary implantable prostheticdevice 1300 is shown. The device 1300 is similar to the device 100,described above, and includes a coaption element 1310, paddles 1320, andclasps or gripping members 1330. Referring now to FIG. 111, a top viewof the coaption element 1310 is shown. As can be seen in FIG. 111, thecoaption element 1310 has a generally oval-shaped cross-section. Thecoaption element 1310 does not include a central opening and can beformed from a solid piece of material, such as foam. Forming thecoaption element 1310 from a solid piece of foam material prohibitsblood from flowing through the center of the coaption element 1310,thereby substantially eliminating a location where blood can becaptured. The device 1300 can include any other features for animplantable prosthetic device discussed in the present application, andthe device 1300 can be positioned to engage valve tissue 20, 22 as partof any suitable valve repair system (e.g., any valve repair systemdisclosed in the present application). The prosthetic device 1300 can beopened and closed in a wide variety of different ways. For example, asleeve can be slidably disposed over the coaption element to engage andopen the paddles. Or, the paddles can be opened by pulling a line orsuture that opens the clasps and the movement of the clasps can open thepaddles. However, any mechanism for opening and closing the device 1300can be used.

Referring now to FIGS. 112-128, an exemplary paddle frame 1400 for animplantable prosthetic device is shown. The paddle frame 1400 can beused with any of the implantable prosthetic devices described in thepresent application. The paddle frame 1400 is formed from a piece ofmaterial 1402, such as nitinol, or any other suitable material. Thepaddle frame 1400 extends from a cap attachment portion 1410 to a paddleconnection portion 1420 and has a proximal portion 1422, a middleportion 1424, and a distal portion 1426. In some embodiments, the paddleframe 1400 includes attachment portions 1440 for securing a cover (seeFIG. 30), the inner paddle 520, and/or the outer paddle 522 to thepaddle frame 1400. In some embodiments, the paddle frame 1400 is thinnerin the location of the fifth curve 1438 to facilitate bending of bothsides of the paddle frame 1400 toward the center plane 1404 during, forexample, crimping of the device.

The paddle frame 1400 extends between a first attachment portion 1412 ina generally rounded, three-dimensional shape through the proximal,middle, and distal portions 1422, 1424, 1426 and returns to a secondattachment portion 1414. To form a rounded three-dimensional shape, thepaddle frame 1400 is bent or curved in multiple locations as the paddleframe 1400 extends between the first and second attachment portions1412, 1414. The attachment portions 1412, 1414 include notches 1416,1418 respectively for attachment to the cap. The paddle frame 1400flexes at the area 1419. The area 1419 can include a wider portion 1417to distribute the stress that results from flexing the paddle frame 1400over a greater area. Also, notches 1416, 1418 can include radiusednotches 1415 at each end of the notches. The radiused notches 1415 serveas strain reliefs for the bending area 1419 and the area where thepaddle frame 1400 connects to the cap.

The paddle frame 1400 curves away from a median or central plane 1404(FIG. 115) at a first curve 1430 to widen the shape of the paddle frame1400. As can be seen in FIG. 117, the paddle frame 1400 also curves awayfrom a frontal plane 1406 in the location of the first curve 1430. Thepaddle frame 1400 curves away from the outward direction of the firstcurve 1430 at a second curve 1432 to form sides of the frame 1400. Thepaddle frame continues to slope away from the frontal plane 1406 in thelocation of the second curve 1432. In some embodiments, the second curve1432 has a larger radius than the first curve 1430. The paddle frame1400 curves away from the frontal plane 1406 at a third curve 1434 asthe paddle frame 1400 continues to curve in the arc of the second curve1432 when viewed from the frontal plane 1406. This curvature at thethird curve 1434 results in a gradual departure of the frame 1400, andthus the native valve leaflet from the centerline 1406. This departurefrom the centerline results in spreading of the leaflet tissue towardthe valve annulus, which can result in less stress on the leaflettissue. The paddle frame 1400 curves toward the lateral plane 1404 at afourth curve 1436 as the frame 1400 continues to curve away from thefrontal plane 1406. The rounded three-dimensional shape of the paddleframe 1400 is closed with a fifth curve 1438 that joins both sides ofthe paddle frame 1400. As can be seen in FIGS. 116 and 118, the paddleframe 1400 has a generally arcuate shape as the frame 1400 extends awayfrom the attachment portion 1420 and to the closed portion 1424. Themiddle portion 1422 of the frame is closer to the frontal plane 1406than the closed portion 1424, giving the sides of the middle portion1422 a rounded, wing-like shape that engages the curved surface ofcoaption element (not shown) during grasping of native tissue between apaddle (not shown) and coaption element of an implantable device of thepresent invention.

Referring to FIG. 191, in another exemplary embodiment, a flat blank1403 of paddle frame 1400 can be cut, for example laser cut, from a flatsheet of material. Referring to FIG. 192, the cut blank 1403 can then bebent to form the three-dimensional shaped paddle frame 1400.

Referring to FIGS. 193 and 194, in one exemplary embodiment, the paddleframes 1400 can be shape-set to provide increased clamping force againstor toward the coaption element 510 when the paddles 520, 522 are in theclosed configuration. This is because the paddle frames are shape-setrelative to the closed position (e.g. FIG. 194) to a first position(e.g., FIG. 193) which is beyond the position where the inner paddle 520would engage the coaption element, such as beyond the central plane 552of the device 500, such as beyond the opposite side of the coaptionelement, such as beyond the outer paddle on the opposite side of thecoaption element. Referring to FIG. 194, the paddle frame 194 is flexedand attached to the inner and outer paddles 522, 520, for example bystitching. This results in the paddle frames having a preload (i.e., theclamping force against or toward the coaption element is greater thanzero) when the paddle frames 1400 are in the closed configuration. Thus,shape-setting the paddle frames 1400 in the FIG. 193 configuration canincrease the clamping force of the paddle frames 1400 compared to paddleframes that are shape-set in the closed configuration (FIG. 194).

The magnitude of the preload of the paddle frames 1400 can be altered byadjusting the degree to which the paddle frames 1400 are shape-setrelative to the coaption element 510. The farther the paddle frames 1400are shape-set past the closed position, the greater the preload.

The curves of the paddle frame 1400 may be independent from one another,that is, one curve is complete before another curve starts, or may becombined, that is, the paddle frame 1400 curves in multiple directionssimultaneously.

Referring now to FIGS. 112A, 114A, 115A, 116A, 117A, and 118A, exemplarypaddle frames 1400A for an implantable prosthetic device are shown. Thepaddle frames 1400A can be used with any of the implantable prostheticdevices described in the present application. Each paddle frame 1400A isformed from a piece of material 1402A, such as nitinol, or any othersuitable material. Each paddle frame 1400A extends from a cap attachmentportion 1410A to a paddle connection portion 1420A and has a proximalportion 1422A, a middle portion 1424A, and a distal portion 1426A.

Each paddle frame 1400A extends between a first attachment portion 1412Ain a generally rounded, three-dimensional shape through the proximal,middle, and distal portions 1422, 1424, 1426 and returns to a secondattachment portion 1414. To form a rounded three-dimensional shape, eachpaddle frame 1400A is bent or curved in multiple locations as the paddleframe 1400A extends between the first and second attachment portions1412A, 1414A. The attachment portions 1412A, 1414A include notches1416A, 1418A respectively for attachment to the cap. The paddle frames1400A flex at the area 1419A. The area 1419A can include a wider portion1417A to distribute the stress that results from flexing the paddleframe 1400A over a greater area. Also, notches 1416A, 1418A can includeradiused notches 1415A at each end of the notches 1416A, 1418A. Theradiused notches 1415A serve as strain reliefs for the bending area1419A and the area where the paddle frame 1400A connects to the cap.

Each paddle frame 1400A curves away from a median or central plane 1404A(FIG. 116A) at a first curve 1430A to widen the shape of the paddleframe 1400A. As can be seen in FIG. 114A, the paddle frame 1400A alsocurves away from a frontal plane 1406A in the location of the firstcurve 1430A. The paddle frame 1400A curves away from the outwarddirection of the first curve 1430A at a second curve 1432A to form sides1433A of the frame 1400A that are substantially parallel to the centralplane 1404A when viewed from the frontal plane 1406A. The paddle framecontinues to slope away from the frontal plane 1406A in the location ofthe second curve 1432A. In some embodiments, the second curve 1432A hasa larger radius than the first curve 1430A. The paddle frame 1400Acurves back toward from the frontal plane 1406A at a third curve 1434Ain the middle portion 1424A while the sides 1433A of the paddle frame1400A remain substantially parallel to the central plane 1404A. Thepaddle frame 1400A curves away from the central plane 1404A a secondtime at a fourth curve 1436A and continues to curve away from thecentral plane 1404A through the remainder of the middle and distalportions 1424A, 1426A. The rounded three-dimensional shape of the paddleframe 1400A is closed by an end portion 1442A connected to the sides1433 by fifth curves 1438A that form rounded corners of the distal end1426A of the paddle frame 1400A.

The end portion 1442A may be wider than the remainder of the paddleframe 1400A to accommodate features that allow the paddle frames 1400Ato be attached to the paddles (not shown) and cover (not shown). Forexample, the end portion 1442A may include a slot 1444A for receiving aportion of a strip of material, such as the strip of material 401A, 501Adescribed above. An opening 1446A in the end portion 1442A allows astrip of material to be inserted into the slot 1446A. The end portion1442A may also include attachment holes 1440A for securing a cover (seeFIG. 30A) to the paddle frame 1400A.

As can be seen in FIGS. 116A and 117A, the paddle frame 1400A has agenerally rounded rectangle shape as the frame extends away from theattachment portion 1410A to the closed end of the paddle connectionportion 1420A. The middle portion 1424A of the frame is closer to thefrontal plane 1406A than the distal portion 1426A, giving the sides ofthe middle portion 1424A a rounded, wing-like shape that engages thefront and back surfaces of the coaption element (not shown) duringgrasping of native tissue between a paddle (not shown) and coaptionelement of an implantable device described herein.

Referring to FIGS. 195 and 196, the paddle frames 1400A are shownassembled to the collar 514A of an exemplary implantable device, such asthe device 500A described above. In one exemplary embodiment, the paddleframes 1400A can be shape-set to provide increased clamping forceagainst or toward a coaption element 510A when the paddles 520A, 522Aare in the closed configuration. This is because the paddle frames 1400Aare shape-set relative to the closed position (e.g., FIG. 196) to afirst position (e.g., FIG. 195) which is beyond the position where theinner paddle 522A would engage the coaption element 510A, such as beyondthe central plane 552A of the device 500A (e.g., FIG. 70A), such asbeyond the opposite side of the coaption element, such as beyond theouter paddle on the opposite side of the coaption element. In the firstposition the sides 1433A of the paddle frames 1400A are intertwined inthat the sides 1433A of one paddle frame 1400A are moved slightlylaterally to allow movement past the sides 1433A of the other paddleframe 1400A until the end portions 1442A of each frame 1400A contacteach other and the sides 1433A and prevent further movement.

The magnitude of the preload of the paddle frames 1400A can be alteredby adjusting the degree to which the paddle frames 1400A are shape-setrelative to the coaption element 510A. The farther the paddle frames1400A are shape-set past the closed position, the greater the preloadforce when the paddle frames 1400A are moved into the open position.

The curves of the paddle frame 1400A may be independent from oneanother, that is, one curve is complete before another curve starts, ormay be combined, that is, the paddle frame 1400A curves in multipledirections simultaneously.

Like the paddle frame 1400 shown in FIGS. 191 and 192, in an exemplaryembodiment, the paddle frame 1400A can be formed from a flat blank thatis cut from a flat sheet of material, for example, by laser cutting. Thecut blank can then be bent to form the three-dimensional shape of thepaddle frame 1400A.

Referring now to FIGS. 119-120, the paddle frame 1400 is shown in anexpanded condition (FIG. 119) and a compressed condition (FIG. 120). Thepaddle frame 1400 is in a compressed condition when the paddles aredisposed in a delivery device 1450. Referring to FIG. 119, the paddleframe 1400 is moved from the expanded condition to the compressedcondition by compressing the paddle in the direction X and extending alength of the paddle in the direction Y. When the paddles 1400 are inthe compressed condition, the paddles have a width H. The width H canbe, for example between about 4 mm and about 7 mm, such as, betweenabout 5 mm and about 6 mm. In alternative embodiments, the width H canbe less than 4 mm or more than 7 mm. In certain embodiments, the width Hof the compressed paddles 1400 is substantially equal to a width D ofthe delivery opening 1452 of the delivery device 1450. The ratio betweenthe width W of the paddles in the expanded condition and the width H ofthe paddles in the compressed condition can be, for example, about 4 to1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less,such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1.In alternative embodiments, the ratio between the width W and the widthH can be more than 4 to 1. FIG. 120 illustrates the connection portions1410 compressed from the positions illustrated by FIG. 119. However, insome exemplary embodiments, the connection portions 1410 will not becompressed. For example, the connection portions 1410 will not becompressed when the connection portions 1410 are connected to a cap 514.The paddle frame 1400A shown in FIGS. 112A and 114A-118A can besimilarly compressed.

Referring now to FIGS. 121-124, the exemplary implantable device 500 isshown in open and closed conditions with paddle frames that arecompressed or stretched as the anchor portion 506 of the device isopened and closed. The paddle frames 1524 are like the paddle frame 1400described above. Referring now to FIG. 121, the anchor portion 506 isshown in a closed condition. Referring now to FIG. 122, the paddleframes 1524 have a first width W1 and a first length L1. Referring nowto FIG. 123, the anchor portion 506 is shown in an open condition andthe paddle frames 1524 are in an extended condition (FIG. 124). Openingthe anchor portion 506 of the device 500 causes the paddle frames 1524to pivot outward from the coaption portion 510 and transition to theextended condition. In the extended condition, the paddle frames 1524have a second or extended length L2 and a second or extended width W2.In the extended condition, the paddle frame 1524 lengthens and narrowssuch that the second length L2 is greater than the first length L1 andthe second width W2 is narrower than the first width W1. One advantageof this embodiment is that the paddle frames become narrower and canhave less chordal engagement during grasping of the leaflets. However,the paddle frames become wide when the implant is closed to enhancesupport of the leaflet. Another advantage of this embodiment is that thepaddle frames also become narrower and longer in the bailout position.The narrower paddle size in the elongated or bailout position can allowfor less chordal entanglement and increased ease of bailout.

Referring now to FIGS. 125-128, the exemplary implantable device 500 isshown in open and closed conditions with paddle frames that arecompressed or stretched as the anchor portion 506 of the device isopened and closed. The paddle frames 1624 are similar to the paddleframe 1400 described above. Referring now to FIG. 125, the anchorportion 506 is shown in a closed condition. Referring now to FIG. 126,the paddle frames 1624 have a first width W1 and a first length L1.Referring now to FIG. 127, the anchor portion 506 is shown in an opencondition and the paddle frames 1624 are in a compressed condition (FIG.128). Opening the anchor portion 506 of the device 500 causes the paddleframes 1624 to pivot outward from the coaption portion 510 andtransition to the compressed condition. In the compressed condition, thepaddle frames 1624 have a second or compressed length L2 and a second orcompressed width W2. In the compressed condition, the paddle frame 1624shortens and widens such that the second length L2 is less than thefirst length L1 and the second width W2 is wider than the first widthW1.

Referring now to FIGS. 129-136, exemplary implantable prosthetic devicesare shown that can be locked or fastened closed. Referring now to FIG.129, the exemplary implantable prosthetic device 500 is shown that canbe locked or retained in a closed condition with magnets. As describedabove, the device 500 includes a coaption element 510 and paddles 520.The paddles 520 open and close to grasp leaflets 20, 22 of the nativeheart valve, as described in more detail above. The coaption element 510includes one or more magnets 1700 and the paddles 520 include one ormore magnets 1702. The magnets 1700, 1702 have opposite poles facingeach other such that the magnets 1702 in the paddles 520 are attractedto the magnets 1700 in the coaption element 510 and the magneticattractive forces between the magnets 1700, 1702 retain the paddles 520in a closed condition. In certain embodiments, the magnets 1700, 1702are programmed or polymagnets with patterns of polarity such that theimplantable device 500 can be locked and unlocked by moving—such asrotating—the magnet 1700 within the coaption element. For example, themagnet 1700 can be configured such that the magnet 1700 attracts themagnets 1702 in the paddles 520 in a first orientation and repels themagnets 1702 in the paddles 520 when the magnet 1700 is rotated 90degrees into a second orientation.

Referring now to FIGS. 130-131, the exemplary implantable prostheticdevice 500 is shown that can be locked or retained in a closed conditionwith an elastic band 1800. The elastic band 1800 can be made from anyflexible material and have any configuration. For example, the elasticband can comprise coiled nitinol, can have a stent like structure, etc.

As described above, the device 500 includes a coaption element 510,paddles 520, and barbed clasps 530. The paddles 520 and barbed clasps530 open and close to grasp leaflets 20, 22 of the native heart valve,as described in more detail above. The paddles 520 move between an opencondition (FIG. 130) to a closed condition (FIG. 131) by actuation of anactuation wire or shaft 512, as described above. The elastic band 1800can be arranged to lock or retain the device 500 in a closed condition.When the device 500 is in the open condition (FIG. 130) the band 1800 isarranged around the paddles 520 in a relaxed or disengaged condition.For example, the band 1800 may be arranged around a narrower portion ofthe open device 500, such as a tapered portion of the paddles 520 near adistal portion 507 of the device. When the device 500 is in the closedcondition (FIG. 131) the band 1800 is arranged around the paddles 520 inan engaged condition. In certain embodiments, when the band 1800 is inthe engaged condition it is arranged around the widest portion of thedevice 500 or can be arranged around the center of the device 500.

The band 1800 is moved from the disengaged condition in a closing orengaging direction 1802 to the engaged condition with sutures (notshown) or other suitable means of moving the band 1800. Movement of theband 1800 can cause the paddles 520 to move in a closing direction 1804,thereby closing and securing the device 500 in a single movement of theband 1800. Alternatively, device 500 may be closed and the band 1800moved into the engaged location to secure the device 500 in the closedcondition.

Referring now to FIG. 132, the exemplary implantable prosthetic device500 is shown that can be locked or retained in a closed condition with abiasing member 1900. As described above, the device 500 includes acoaption element 510, paddles 520, and barbed clasps 530. The paddles520 are moved between open and closed positions with an actuation wire512 extending through the coaption element 510 to a cap 514. The paddles520 and barbed clasps 530 are opened and closed to grasp leaflets 20, 22of the native heart valve, as described in more detail above. In theclosed condition, the paddles 520 and the clasps 530 engage the tissueof valve leaflets 20, 22 and each other to secure the device 500 to thevalve tissue.

The biasing member 1900 (e.g., a spring) is configured to bias the cap514 toward the coaption element 510, thereby biasing the device 500toward the closed condition. After the device 500 is delivered to andattached to the valve tissue with a delivery device (not shown), thedelivery device is removed from the patient's body and the biasingmember 1900 maintains the device 500 in a closed condition to preventdetachment of the device 500 from the valve tissue.

Referring now to FIGS. 133-134, an exemplary implantable prostheticdevice 2000 is shown that can be locked or retained in a closedcondition with latches. The device 2000 can include any other featuresfor an implantable prosthetic device discussed in the presentapplication, and the device 2000 can be positioned to engage valvetissue 20, 22 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application).

The device 2000 is similar to other implantable devices described aboveand includes paddles 2002 and gripping members or clasps 2004. Thepaddles 2002 are opened and closed to grasp the native leaflets 20, 22in a gap 2006 between the paddles 2002 and gripping members 2004. Thedevice 2000 also includes a latch member 2008 attached to the paddles2002, in which the latch member 2008 is configured to attach the paddles2002 to the gripping members 2004 when the device 2000 is in the closedposition. In some embodiments, the latch member 2008 serves as asecondary latching mechanism and is configured to keep the device 2000in the closed position when other mechanisms fail.

Referring to FIG. 133, the device 2000 is in an open position with valvetissue 20, 22 disposed in the gap or opening 2006 between the paddles2002 and the gripping members 2004. Referring to FIG. 134, the device2000 is moved to the closed position such that the valve tissue 20, 22is secured between the paddles 2002 and the gripping members 2004. Thedevice 2000 can be moved to the closed position by any suitable manner,such as, for example, any manner described in the present application.When the device 2000 is moved to the closed position, the latch member2008 punctures the valve tissue 20, 22 and is inserted into or throughthe gripping member 2004 to secure the paddle 2002 to the grippingmember 2004. The latch member 2008 can take any suitable form that cansecure the paddles 2002 to the gripping members 2004, such as, forexample, metals, plastics, etc.

Referring now to FIGS. 135-136, the exemplary implantable prostheticdevice 2000 is shown that can be locked or retained in a closedcondition with latches. In FIGS. 135-136, the device 2000 includes acoaption element 2010. Referring to FIG. 135, the device 2000 is in anopen position with valve tissue 20, 22 disposed in the gap or opening2006 between the paddles 2002 and the gripping members 2004. Referringto FIG. 136, the device 2000 is moved to the closed position such thatthe valve tissue 20, 22 is secured between the paddles 2002 and thegripping members 2004. The device 2000 can be moved to the closedposition by any suitable manner, such as, for example, any mannerdescribed in the present application. When the device 2000 is moved tothe closed position, the latch member 2008 punctures the valve tissue20, 22 and is inserted into or through the gripping member 2004 tosecure the paddle 2002 to the gripping member 2004. In the illustratedembodiment, the latch member 2008 protrudes beyond the gripping members2004 and into the coaption element 2010. In some embodiments, the latchmember 2008 may be secured in the coaption element 2010 by latching ontoa portion of the coaption element 2010 or by penetrating the coaptionelement 2010 material. The latch member 2008 can take any suitable formthat can secure the paddles 2002 to the gripping members 2004, such as,for example, metals, plastics, etc.

Referring now to FIGS. 137-145, various embodiments of implantableprosthetic devices and methods of using the same are shown thatfacilitate release of native tissue grasped by the implantableprosthetic devices. The devices can include any other features for animplantable prosthetic device discussed in the present application, andthe devices can be positioned to engage valve tissue 20,22 as part ofany suitable valve repair system (e.g., any valve repair systemdisclosed in the present application).

Referring now to FIG. 137, a device 2100 with stretchable clasps orgripping members is shown. The device 2100 is delivered from a deliverysheath 2102 and has a coaption element 2110, paddles 2120, and clasps orgripping members 2130. The gripping members 2130 include barbs 2132 andstretchable portions 2134. The stretchable portions 2134 allow theclasps 2130 to be stretched in a stretching direction 2136. Actuationsutures 2104 extend from the delivery sheath 2102 to the clasps 2130.Retracting the sutures 2104 in a retraction direction 2106 opens andstretches the clasps 2130 to a fully extended position. In certainembodiments, the clasps 2130 primarily stretch once the clasps 2130 arein the fully open position. Movement of the barbs 2132 in the stretchingdirection 2136 allows for clean disengagement from the native tissue. Insome embodiments, the stretchable portion 2134 is configured to be movedsuch that the barbs 2132 exit the valve tissue in a directionsubstantially opposite the direction in which the barbs entered thenative tissue. Alternatively, the clasps 2130 can be otherwiseextendable to allow for disengagement from the native tissue withouttearing the native tissue. For example, joint portions 2131 can beconfigured to allow the barbs 2132 of the clasps 2130 to be pulled inthe direction 2136.

Referring now to FIGS. 138-143, two exemplary embodiments of methods ofreleasing valve tissue from the prosthetic device 500 are shown. Asdescribed above, the device 500 includes a coaption element 510, innerpaddles 522, outer paddles 520, and barbed clasps 530. The device 500 isdeployed from a delivery sheath 502. An actuation wire 512 extendsthrough the coaption element 510 to a cap 514. Actuation of theactuation wire 512 opens and closes the paddles 520,522 to open andclose the device. The barbed clasps 530 include barbs 536, moveable arms534, and stationary arms 532. The stationary arms 532 are attached tothe inner paddles 522 so that the clasps 530 move with the movement ofthe inner paddles 522. Actuation sutures 537 extend from the deliverysheath 502 to the moveable arms 534 of the clasps 530.

FIGS. 138-141 illustrate an exemplary method of releasing grasped valvetissue. In the example illustrated by FIGS. 138-141, the device is shownin a substantially open position to more clearly illustrate themovements of the parts of the device 500 that are involved with tissuerelease. However, in practice the tissue release method is more likelyto be practiced with the device 500 in the more closed positionsillustrated by FIGS. 142 and 143. That is, it is not likely that thepaddles and clasps will be substantially opened before moving the claspsto release the valve tissue as illustrated by FIGS. 138-141. It is morelikely that the paddles and clasps will only be opened slightly beforereleasing the valve tissue as illustrated by FIGS. 142 and 143. The sameparts that move in the example illustrated by FIGS. 138-141 move in theexample illustrated by FIGS. 142-143.

Referring now to FIG. 138, the device 500 is shown in a substantiallyopen position with the clasps 530 in a closed position. Retraction ofthe actuation sutures 537 pivots the moveable arms 534 of the clasps 530to a partially open position (FIG. 139) and then to a fully openposition (FIG. 140). Referring now to FIG. 141, once the clasps 530 arein the fully open position (FIG. 140), further retraction of theactuation sutures 537 in the retraction direction 560 pulls upward onthe moveable arms 534, barbs 536, and inner paddles 522 in a tissuerelease direction. The portion 523 of the inner paddles 522 closest tothe coaption element flex upward in direction 562 to allow this movementin the retraction direction 560. There can optionally be a small gapG₁₄₀ between the claps 530 and the coaption element 510. The innerpaddles can flex at the small gap (if there is a small gap) or at theconnection 523 between the coaption element 510 and the inner paddles ifthere is not a gap. This flexing movement 562 of the inner paddles 522can optionally also cause the outer paddles to pivot downward. Movementof the barbs 536 in the tissue release direction 560 allows for cleandisengagement from the native tissue. The barbs can be at an angle θ(see FIG. 138) to the moveable arms 534 that facilitates release fromthe tissue. For example, the angle θ can be between 10 and 60 degrees,such as 20 and 50 degrees, such as 25 and 45 degrees, such as about 30degrees, or 30 degrees.

Referring now to FIGS. 142-143, the device 500 is shown in a slightlyopened position or a closed position. As mentioned above, the same partsof the device 500 move in the example illustrated by FIGS. 142 and 143as in the example illustrated by FIGS. 138-141. In the partially openposition or closed position, further retraction of the actuation sutures537 in the retraction direction 560 pulls upward on the moveable arms534, barbs 536, and inner paddles 522. The portion of the inner paddles522 closest to the coaption element flexes or is lifted-up in thedirection 562 to allow the movement 560. As mentioned above, there canoptionally be a small gap G₁₄₀ between the clasps 530 and the coaptionelement 510. The inner paddles can flex 562 at the small gap (if thereis a small gap) or at the connection between the coaption element 510and the inner paddles if there is not a gap. The movement of the barbs536 in the direction 560 releases the valve tissue from the barbs. Thelifting on the inner paddles 522 can optionally also force the outerpaddles 520 to move outward in an opening direction 564. The optionaloutward movement 564 of the outer paddles 520 relieves the pinchingforce applied to grasped tissue by the paddles and the coaption element.Relieving the pinching force on the tissue can also assist in therelease of the tissue from the barbs. In one exemplary embodiment, thedevice 500 is moved from the position illustrated by FIG. 143 to theposition illustrated by FIG. 140 or 141 to fully disengage the devicefrom the native valve.

FIGS. 144-152 show an exemplary delivery assembly 2200 and itscomponents. Referring to FIG. 144, the delivery assembly 2200 cancomprise the implantable prosthetic spacer device 500 (or any otherimplantable device described in the present application) and a deliveryapparatus 2202. The delivery apparatus 2202 can comprise a plurality ofcatheters and catheter stabilizers. For example, in the illustratedembodiment, the delivery apparatus 2202 includes a first catheter 2204,a second catheter 2206, a third catheter 2208, and catheter stabilizers2210. The second catheter 2206 extends coaxially through the firstcatheter 2204, and the third catheter 2208 extends coaxially through thefirst and second catheters 2204, 2206. The prosthetic spacer device 500can be releasably coupled to a distal end portion of the third catheter2208 of the delivery apparatus 2202, as further described below.

In the illustrated embodiment, the delivery assembly 2200 is configured,for example, for implanting the prosthetic spacer device 500 in a nativemitral valve via a transseptal delivery approach. In other embodiments,the delivery assembly 2200 can be configured for implanting theprosthetic spacer device 500 in aortic, tricuspid, or pulmonary valveregions of a human heart. Also, the delivery assembly 2200 can beconfigured for various delivery methods, including transseptal,transaortic, transventricular, etc.

Referring to FIG. 146, the first collar or cap 514 of the prostheticspacer device 500 can include a bore 516A. In some embodiments, the bore516A can comprise internal threads configured to releasably engagecorresponding external threads on a distal end 512B of the actuationshaft or means of actuating 512 of the delivery apparatus 2202, as shownin FIG. 145.

Referring again to FIG. 146, the second or proximal collar 511 of theprosthetic spacer device 500 can include a central opening 511C that isaxially aligned with the bore 516A of the cap 514. The central opening511C of the proximal collar 511 can be configured to slidably receivethe actuation shaft or means of actuating 512 of the delivery apparatus2202, as shown in FIG. 145. In some embodiments, the proximal collar 511and/or the coaption element 510 can have a sealing member (not shown,but see, e.g., the sealing member 413 shown in FIG. 23) configured toseal the central opening 511C when the actuation shaft or means ofactuating 512 is withdrawn from the central opening 511C.

As shown in FIG. 146, the proximal collar 511 can also include aplurality of engagement portions or projections 511A and a plurality ofguide openings 511B. The projections 511A can extending radiallyoutwardly and can be circumferentially offset (e.g., by about 90degrees) relative to the guide openings 511B. The guide openings 511Bcan be disposed radially outwardly from the central opening 511C. Theprojections 511A and the guide openings 511B of the proximal collar 511can be configured to releasably engage a coupler or means for coupling2214 of the delivery apparatus 2202, as shown in FIG. 145.

Referring again to FIG. 144 and as mentioned above, the deliveryapparatus 2202 can include the first and second catheters 2204, 2206.The first and second catheters 2204, 2206 can be used, for example, toaccess an implantation location (e.g., a native mitral valve region of aheart) and/or to position the third catheter 2208 at the implantationlocation.

The first and second catheters 2204, 2206 can comprise first and secondsheaths 2216, 2218, respectively. The catheters 2204, 2206 can beconfigured such that the sheaths 2216, 2218 are steerable. Additionaldetails regarding the first catheter 2204 can be found, for example, inU.S. Published Patent Application No. 2016/0155987, which isincorporated by reference herein in its entirety. Additional detailsregarding the second catheter 2206 can be found, for example, in U.S.Provisional Patent Application No. 62/418,528, which is incorporated byreference herein in its entirety.

Referring still to FIG. 144, delivery apparatus 2202 can also includethe third catheter 2208, as mentioned above. The third catheter 2208 canbe used, for example, to deliver, manipulate, position, and/or deploythe prosthetic spacer device 500 at the implantation location.

Referring to FIG. 148, the third catheter 2208 can comprise theactuation or inner shaft 512, the coupler or means for coupling 2214, anouter shaft 2220, a handle 2222 (shown schematically), and clasp controlmembers 537. A proximal end portion 2220 a of the outer shaft 2220 canbe coupled to and extend distally from the handle 2222, and a distal endportion 2220 b of the outer shaft 2220 can be coupled to the coupler ormeans for coupling 2214. A proximal end portion 512A of the actuationshaft or means of actuating 512 can coupled to an actuation knob 2226.The actuation shaft or means of actuating 512 can extend distally fromthe knob 2226 (shown schematically), through the handle 2222, throughthe outer shaft 2220, and through the coupler or means for coupling2214. The actuation shaft or means of actuating 512 can be moveable(e.g., axially and/or rotationally) relative to the outer shaft 2220 andthe handle 2222. The clasp control members 537 can extend through and beaxially movable relative to the handle 2222 and the outer shaft 2220.The clasp control members 537 can also be axially movable relative tothe actuation shaft or means of actuating 512.

As shown in FIGS. 145-146, the actuation shaft or means of actuating 512of the third catheter 2208 can be releasably coupled to the cap 514 ofthe prosthetic spacer device 500. For example, in some embodiments, thedistal end portion 512B of the actuation shaft or means of actuating 512can comprise external thread configured to releasably engage theinterior threads of the bore 516A of the prosthetic spacer device 500.As such, rotating the actuation shaft or means of actuating 512 in afirst direction (e.g., clockwise) relative to the cap 514 of theprosthetic spacer device 500 releasably secures the actuation shaft ormeans of actuating 512 to the cap 514. Rotating the actuation shaft ormeans of actuating 512 in a second direction (e.g., counterclockwise)relative to the cap 514 of the prosthetic spacer device 500 releases theactuation shaft or means of actuating 512 from the cap 514.

Referring now to FIGS. 145-147, the coupler or means for coupling 2214of the third catheter 2208 can be releasably coupled to the proximalcollar 511 of the prosthetic spacer device 500. For example, in someembodiments, the coupler or means for coupling 2214 can comprise aplurality of flexible arms 2228 and a plurality of stabilizer members2230. The flexible arms 2228 can comprise apertures 2232, ports 2233(FIG. 146), and eyelets 2234 (FIG. 147). The flexible arms 2228 can beconfigured to pivot between a first or release configuration (FIG. 146)and a second or coupled configuration (FIGS. 145 and 147). In the firstconfiguration, the flexible arms 2228 extend radially outwardly relativeto the stabilizer members 2230. In the second configuration, theflexible arms 2230 extend axially parallel to the stabilizer members2230 and the eyelets 2234 radially overlap 2234, as shown in FIG. 147.The flexible arms 2228 can be configured (e.g., shape-set) to be biasedto the first configuration.

The prosthetic spacer device 500 can be releasably coupled to thecoupler or means for coupling 2214 by inserting the stabilizer members2230 of the coupler or means for coupling 2214 into the guide openings511B of the prosthetic spacer device 500. The flexible arms 2228 of thecoupler or means for coupling 2214 can then be pivoted radially inwardlyfrom the first configuration to the second configuration such that theprojections 511A of the prosthetic spacer device 500 extend radiallyinto the apertures 2232 of the flexible arms 2228. The flexible arms2228 can be retained in the second configuration by inserting the distalend portion 512B of the actuation shaft or means of actuating 512through openings 2236 of the eyelets 2234, which prevents the flexiblearms 2228 from pivoting radially outwardly from the second configurationto the first configuration, thereby releasably coupling the prostheticspacer device 500 to the coupler or means for coupling 2214.

The prosthetic spacer device 500 can be released from the coupler ormeans for coupling 2214 by proximally retracting the actuation shaft ormeans of actuating 512 relative to the coupler or means for coupling2214 such that the distal end portion 512B of the actuation shaft ormeans of actuating 512 withdraws from the openings 2236 of the eyelets2234. This allows the flexible arms 2228 to pivot radially outwardlyfrom the second configuration to the first configuration, whichwithdraws the projections 511A of the prosthetic spacer device 500 fromthe apertures 2232 of the flexible arms 2228. The stabilizer members2230 can remain inserted into the guide openings 511B of the prostheticspacer device 500 during and after the flexible arms 2228 are released.This can, for example, prevent the prosthetic spacer device 500 frommoving (e.g., shifting and/or rocking) while the flexible arms 2228 arereleased. The stabilizer members 2230 can then be withdrawn from theguide openings 511B of the prosthetic spacer device 500 by proximallyretracting the coupler or means for coupling 2214 relative to theprosthetic spacer device 500, thereby releasing the prosthetic spacerdevice 500 from the coupler or means for coupling 2214.

Referring to FIG. 148, the outer shaft 2220 of the third catheter 2208can be an elongate shaft extending axially between the proximal endportion 2220 a, which is coupled to the handle 2222, and the distal endportion 2220 b, which is coupled to the coupler or means for coupling2214. The outer shaft 2220 can also include an intermediate portion 2220c disposed between the proximal and distal end portions 2220 a, 2220 b.

Referring to FIG. 149, the outer shaft 2220 can comprise a plurality ofaxially extending lumens, including an actuation shaft or means ofactuating lumen 2238 and a plurality of control member lumens 2240(e.g., four in the illustrated embodiment). In some embodiments, theouter shaft 2220 can comprise more (e.g., six) or less (e.g., two) thanfour control member lumens 2240.

The actuation shaft or means of actuating lumen 2238 can be configuredto receive the actuation shaft or means of actuating 512, and thecontrol member lumens 2240 can be configured to receive one or moreclasp control members 537. The lumens 2238, 2240 can also be configuredsuch that the actuation shaft or means of actuating 512 and claspcontrol members 537 can be movable axially and/or rotationally) relativeto the respective lumens 2238, 2240. In particular embodiments, thelumens 2238, 2240 can comprise a liner or coating configured to reducefriction within the lumens 2238, 2240. For example, the lumens 2238,2240 can comprise a liner comprising PTFE.

Referring still to FIGS. 148-149, the outer shaft 2220 can be formedfrom various materials, including metals and polymers. For example, inone particular embodiment, the proximal end portion 2220 a can comprisestainless steel and the distal and intermediate portions 2220 b, 2220 ccan comprise PEBAX (e.g., PEBAX®). The outer shaft 2220 can alsocomprise an outer covering or coating, such as a polymer that isreflowed over the portions 2220 a, 2220 b, and 2220 c.

The outer shaft 2220 can include one or more coil portions 2242 disposedradially outwardly from the lumens 2238, 2240. For example, in oneparticular embodiment, the outer shaft 2220 can comprise a first coil2242 a, a second coil 2242 b, and a third coil 2242 c. The first coil2242 a can be the radially outermost coil, the third coil 2242 c can bethe radially innermost coil, and the second coil 2242 b can be radiallydisposed between the first coil 2242 a and the third coil 2242 c.

The coil portions 2242 can comprise various materials and/orconfigurations. For example, the coil portions 2242 can be formed fromstainless steel. In one particular embodiment, the first and third coils2242 a, 2242 c comprise stainless steel coils wound in a left handconfiguration, and the second coil 2242 b comprises a stainless steelcoil wound in a right hand configuration.

The coil portions 2242 can also comprise various pitches. The pitch ofone or more of the coils 2242 can be the same or different than thepitch of one or more other coils 2242. In one particular embodiment, thefirst and second coils 2242 a, 2242 b can have a first pitch (e.g., 0.74in.), and the third coil can comprise a second pitch (e.g., 0.14 in.).

The outer shaft 2220 can also comprise a tie layer 2244 disposedradially inwardly from the third coil 2242 c. The tie layer 2244 can beformed of various materials including polymers, such as PEBAX (e.g.,PEBAX®).

As shown in FIGS. 150-152, the handle 2222 of the third catheter 2208can include a housing 2246, an actuation lock mechanism 2248, a claspcontrol mechanism 2250, and a flushing mechanism 2252. Referring to FIG.150, a distal end portion of the housing 2246 can be coupled to theproximal end portion 2220 a of the outer shaft 2220. The actuation lockmechanism 2248, the clasp control mechanism 2250, and a flushingmechanism 2252 can be coupled to a proximal end of the housing 2246. Theactuation lock mechanism 2248 can be configured to selectively lock theposition of the actuation shaft or means of actuating 512 relative tothe housing 2246 and the outer shaft 2220. The clasp control mechanism2250 can also be coupled to proximal end portions of the clasp controlmembers 537 and can be configured to secure the clasp control members537 relative to the handle 2222 and to move the clasp control members537 relative to the outer shaft 2220 and the actuation shaft or means ofactuating 512. The flushing mechanism 2252 can be configured forflushing (e.g., with a saline solution) the outer shaft 2220 prior toinserting the outer shaft 2220 into a patient's vasculature.

As shown in FIGS. 151-152, the housing 2246 of the handle 2222 cancomprise a main body 2254 and a nose portion 2256 coupled to a distalend portion of the main body 2254. The main body 2254 and the noseportion 2256 can be coupled together in various manners, includingfasteners 2258 and/or pins 2260 (e.g., as shown in the illustratedembodiment), adhesive, and/or other coupling means. The housing 2246 canbe formed from various materials, including polymers (e.g.,polycarbonate).

The main body 2254 of the housing 2246 can comprise a plurality oflumens, including an actuation shaft or means of actuating lumen 2262,control member lumens 2264 (FIG. 152), and a flushing lumen 2266 thatconnects with the actuation shaft or means of actuating lumen 2262 (FIG.151). As shown in FIG. 152, the main body 2254 can also include aplurality of tubes (e.g., hypotubes), including an actuation tube 2268and control member tubes 2270 that are disposed at least partially inthe actuation shaft or means of actuating lumen 2262 and the controlmember lumens 2264, respectively. The tubes 2268, 2270 can be axiallymovable (e.g., slidable) relative the lumens 2262, 2264, respectively.

The proximal end of the actuation tube 2268 can extend proximally fromthe main body 2256 and can be coupled to the knob 2226 and to theproximal end portion 512A of the actuation shaft or means of actuating512. The proximal ends of the control member tubes 2270 can extendproximally from the main body 2254 and can be coupled to the claspcontrol mechanism 2250 and the clasp control members 537.

The distal ends of the tubes 2268, 2270 can comprise flanges 2272, 2274configured to engage a stopper to limit the axial movement of the tubes2268, 2270 relative to the housing 2224. For example, the flanges 2272,2274 can be configured to contact respective surfaces of the main body2254 (e.g., a lip) to prevent to tubes 2268, 2270 from withdrawingcompletely from the proximal ends of the lumens 2262, 2264,respectively.

The actuation tube 2268 can be configured to receive and be coupled tothe proximal end portion of the actuation shaft or means of actuating512. The control member tubes 2270 can be configured to receive portionsof the clasp control mechanism 2250, as further described below. Thetubes 2268, 2270 can be formed from various materials, includingpolymers and metals (e.g., stainless steel).

In some embodiments, the main body 2254 can include a plurality of sealmembers 2276 (e.g., O-rings) configured to prevent or reduce bloodleakage through the lumens and around the shafts and/or tubes. The sealmembers can be secured relative to the main body 2254, for example, byfasteners 2278 (e.g., hollow-lock or socket-jam set screws).

As shown in FIG. 152, the nose portion 2256 of the housing 2246 cancomprise a plurality of lumens, including an actuation shaft or means ofactuating lumen 2280 and control member lumens 2282. The actuation shaftor means of actuating lumen 2280 of the nose portion 2256 can be extendcoaxially with the actuation shaft or means of actuating lumen 2262 ofthe main body 2254. Proximal ends of the control member lumens 2282 ofthe nose portion 2256 can be aligned with the control member lumens 2264of the main body 2254 at the proximal end of the nose portion 2256(i.e., the lumens 2282, 2264 are in the same plane). The control memberlumens 2282 can extend from the proximal ends at an angle (i.e.,relative to the control member lumens 2264 of the main body 2254), anddistal ends of the control member lumens 2282 can connect with theactuation shaft or means of actuating lumen 2280 of the nose portion2256 at a location toward the distal end of the nose portion 2256. Inother words, the proximal ends of the lumens 2282 are in a first plane(i.e., the plane of the control member lumens 2264 of the main body2254), and the distal ends of the lumens 2282 are in a second plane(i.e., the plane of the actuation shaft or means of actuating lumen 2262of the main body 2254).

As shown in FIG. 151, the actuation shaft or means of actuating lumen2280 of the nose portion 2256 can be configured to receive the proximalend portion of the outer shaft 2220. The proximal end portion of theouter shaft 2220 can be coupled to the nose portion 2256 in many wayssuch as with adhesive, fasteners, frictional fit, and/or other couplingmeans.

Referring still to FIG. 151, the actuation lock mechanism 2248 of thehandle 2222 can be coupled to the proximal end portion of the main body2254 of the housing 2246 and to the actuation tube 2268. The actuationlock mechanism 2248 can be configured to selectively control relativemovement between the actuation tube 2268 and the housing 2246. This, inturn, selectively controls relative movement between the actuation shaftor means of actuating 512 (which is coupled to the actuation tube 2268)and the outer shaft 2220 (which is coupled to the nose portion 2256 ofthe housing 2246).

In some embodiments, the actuation lock mechanism 2248 can comprise alock configuration, which prevents relative movement between theactuation tube 2268 and the housing 2246, and a release configuration,which allows relative movement between the actuation tube 2268 and thehousing 2246. In some embodiments, the actuation lock mechanism 2248 canbe configured to include one or more intermediate configurations (i.e.,in addition to the lock and release configuration) which allow relativemovement between the actuation tube 2268 and the housing 2246, but theforce required to cause the relative movement is greater than when theactuation lock mechanism is in the release configuration.

As shown in FIG. 151 of the illustrated embodiment, the actuation lockmechanism 2248 can comprise a lock (e.g., a Tuohy-Borst adapter) 2284and a coupler (e.g., a female luer coupler) 2286. The coupler 2286 canbe attached to the distal end of the lock 2284 and coupled to theproximal end of the main body 2254 of the housing 2246. The actuationtube 2268 can coaxially extend through the lock 2284 and the coupler2286. As such, rotating a knob 2288 of the lock 2284 in a firstdirection (e.g., clockwise) can increase the frictional engagement ofthe lock 2284 on the actuation tube 2268, thus making relative movementbetween the actuation tube 2268 and the housing 2246 more difficult orpreventing it altogether. Rotating a knob 2288 of the lock 2284 in asecond direction (e.g., counterclockwise) can decrease the frictionalengagement of the lock 2284 on the actuation tube 2268, thus makingrelative movement between the actuation tube 2268 and the housing 2246easier.

In other embodiments, actuation lock mechanism 2248 can comprise otherconfigurations configured for preventing relative movement between theactuation tube 2268 and the housing 2246. For example, the lockingmechanism 2248 can include lock configured like a stopcock valve inwhich a plunger portion of valve selectively engages the actuation tube2268.

The clasp control mechanism 2250 can comprise an actuator member 2290and one or more locking members 2292 (e.g., two in the illustratedembodiment). A distal end portion of the actuator member 2290 can becoupled to the control member tubes 2270, which extend from the proximalend of the main body 2254 of the housing 2246, as best shown in FIG.151. The locking members 2292 can be coupled to a proximal end portionof the actuator member 2290.

As shown in the illustrated embodiment, the actuator member 2290 can,optionally, comprise a first side portion 2294 and a second side portion2296 selectively coupled to the first side portion 2294 by a connectingpin 2298. The actuator member 2290 can be configured such that the firstand second side portions 2294, 2296 move together when the connectingpin 2298 is inserted through the first and second side portions 2294,2296. When the connecting pin 2298 is withdrawn, the first and secondside portions 2294, 2296 can be moved relative to each other. This canallow the clasp control members 537 (which are releasably coupled to thefirst and second side portions 2294, 2296 by the locking elements 2292)to be individually actuated.

The connection between the first and second side portions 2294, 2296 canbe configured such that the first and second side portions 2294, 2296can move axially (i.e., proximally and distally) but not rotationallyrelative to each other when the connecting pin 2298 is withdrawn. Thiscan be accomplished, for example, by configuring the first side portion2294 with keyed slot or groove and configuring second side portion 2296with a keyed projection or tongue that corresponds to the keyed slot orgroove of the first side portion 2294. This can, for example, prevent orreduce the likelihood that the clasp control members 537 from twistingrelative to the outer shaft 2220.

The first and second side portions 2294, 2296 can include axiallyextending lumens 2201. Distal ends of the lumens 2201 can be configuredto receive the proximal end portions of the control member tubes 2270.Proximal ends of the lumens 2201 can be configured to receive portionsof the locking members 2292.

The locking members 2292 can be configured to selectively controlrelative movement between a clasp control member 2224 and the respectivefirst or second side portion 2294, 2296 of the actuator member 2290. Thelocking members 2292 can comprise a lock configuration, which preventsrelative movement between a clasp control member 2224 and the respectivefirst or second side portion 2294, 2296, and a release configuration,which allows relative movement between a clasp control member 2224 andthe respective first or second side portion 2294, 2296. In someembodiments, the locking members 2292 can also comprise one or moreintermediate configurations (i.e., in addition to the lock and releaseconfiguration) which allows relative movement between a clasp controlmember 2224 and the respective first or second side portion 2294, 2296,but the force required to cause the relative movement is greater thanwhen the locking members 2292 are in the release configuration.

As shown in the illustrated embodiment, the locking members 2292 can beconfigured similar to stopcock valves. Thus, rotating knobs 2203 in afirst direction (e.g., clockwise) can increase the frictional engagementbetween the locking members 2292 on the clasp control members 537 andmake relative movement between a clasp control member 2224 and therespective first or second side portion 2294, 2296 more difficult orprevent it altogether. Rotating knobs 2203 in a second direction (e.g.,counterclockwise) can decrease the frictional engagement between thelocking members 2292 on the clasp control members 537 and make relativemovement between a clasp control member 2224 and the respective first orsecond side portion 2294, 2296 easier. In other embodiments, actuationlocking members 2292 can comprise other configurations configured forpreventing relative movement between the locking members 2292 on theclasp control members 537.

The flushing mechanism 2252 can comprise a flushing tube 2205 and avalve 2207 (e.g., a stopcock valve). A distal end of the flushing tube2205 can be coupled to and in fluidic communication with the flushinglumen 2266 and thus with the actuation shaft or means of actuating lumen2262 of the main body 2254. A proximal end of the flushing tube 2205 canbe coupled to the valve 2207. In this manner, the flushing mechanism2252 can be configured for flushing (e.g., with a saline solution) theouter shaft 2220 prior to inserting the outer shaft 2220 into apatient's vasculature.

The clasp control members 537 can be configured to manipulate theconfiguration of the clasps 530, as further described below. As shown inFIG. 148, each of the clasp control members 537 can be configured as asuture (e.g., wire or thread) loop. Proximal end portions of the controlmembers 537 can extend proximally from the proximal end portion of theclasp control mechanism 2250 and can be releasably coupled to thelocking mechanisms 2292 of the clasp control mechanism 2250.

From the locking mechanisms 2292, the clasp control members 537 can formloops extending distally through the lumens 2201 of the clasp controlmechanism 2250, through the control member tubes 2270, the controlmember lumens 2264, 2282 of the handle 2222, and through the controlmember lumens 2240 of the outer shaft 2220. The clasp control members537 can extend radially outwardly from the lumens 2240, for example,through the ports 2233 (FIG. 146) of the coupler or means for coupling2214. The clasp control members 537 can then extend through openings 535of the clasps 530. The clasp control members 537 can then extendproximally back to the coupler or means for coupling 2214, radiallyinwardly through the ports 2233 of the coupler or means for coupling2214, and then proximally through the outer shaft 2220 and the handle2222, and to the locking mechanisms 2292 of the clasp control mechanism2250.

In FIG. 148, the clasp control members 537 are shown slacken and theclasps 530 are partially open in order to illustrate the clasp controlmembers 537 extending through the openings 535 of the clasps 530.However, ordinarily when the clasp control members 537 are slacken, theclasps 530 would be in the closed configuration.

As shown in the illustrated embodiment, each of the clasp controlmembers 537 can extend through multiple lumens 2240 of the outer shaft2220. For example, each of the clasp control members 537 can be loopedthrough two of the lumens 2240. In other embodiments, each of the claspcontrol members 537 can be disposed in a single lumen 2240. In yet otherembodiments, multiple clasp control members 537 can be disposed in asingle lumen 2240.

With the clasp control members 537 coupled to the clasps 530, the claspcontrol mechanism 2250 can be used to actuate the clasps 530 betweenopen and closed configurations. The clasps 530 can be opened by movingthe actuator member 2290 proximally relative to the knob 2226 and thehousing 2246. This increases tension of the clasp control members 537and causes the clasp 530 to move from the closed configuration to theopen configuration. The clasps 530 can be closed by moving the actuatormember 2290 distally relative to the knob 2226 and the housing 2246.This decreases tension on the clasp control members 537 and allows theclasp 530 to move from the open configuration to the closedconfiguration. The clasps 530 can be individually actuated by removingthe pin 2298 and moving the first or second side portions 2294, 2296relative to each other, the knob 2226, and the housing 2246.

When the handle 2222 is assembled as best shown in FIGS. 150-151, theactuation shaft or means of actuating 512 can extend distally from theknob 2226, through the actuation tube 2268, through the actuation lumens2262,2280 of the housing 2246, through the actuation lumen 2238 of theouter shaft 2220, and through the coupler or means for coupling 2214.

Referring now to FIGS. 153-160, the delivery assembly 2200 is used, forexample, to implant the prosthetic spacer device 500 in native mitralvalve MV of a heart H using a transseptal delivery approach. FIGS.153-160 are similar to FIGS. 15-20, described above, that show theimplantable prosthetic device 100 being implanted in the heart H andFIGS. 35-46, described above, that show the implantable prostheticdevice 500 being implanted in the heart H. Although not shown, a guidewire can be inserted into the patient's vasculature (e.g., a femoralvein) through an introducer sheath. The guide wire can be advancedthrough the femoral vein, through the inferior vena cava, into the rightatrium, through the interatrial septum IAS (e.g., via the fossa ovalis),and into the left atrium LA. The first sheath 2216 of the first catheter2204 can be advanced over the guide wire such that a distal end portionof the first sheath 2216 is disposed in the left atrium LA, as shown inFIG. 153.

With the prosthetic spacer device 500 coupled to the third catheter 2208(e.g., as shown in FIG. 145) and configured in a radially compressed,delivery configuration, the prosthetic spacer device 500 can be loadedinto the first sheath 2216 at a distal end of the second sheath 2218 ofthe second catheter 2206. The first sheath 2216 retains the prostheticspacer device 500 in the delivery configuration. In some embodiments,the radially compressed, delivery configuration can be an axiallyelongated configuration (e.g., like the configuration shown in FIG.153). In other embodiments, the radially compressed, deliveryconfiguration can be an axially foreshorten configuration (e.g., similarto the configuration shown in FIG. 155). The second catheter 2206 alongwith the prosthetic spacer device 500 and the third catheter 2208 canthen be advanced together through the first catheter 2204 such that adistal end portion of the sheath 2218 exposed from the distal endportion of the first sheath 2216 and is disposed in the left atrium LA,as shown in FIG. 153.

As shown in FIG. 153, the prosthetic spacer device 500 can be exposedfrom the first sheath 2216 by distally advancing the outer shaft 2220and the actuation shaft or means of actuating 512 of the third catheter2208 relative to the first sheath 2216 and/or retracting the firstsheath 2216 relative to the outer shaft 2220 and the actuation shaft ormeans of actuating 512, thus forcing the paddles 520, 522 of the anchors508 out of the first sheath 2216. Once exposed from the first sheath2216, the paddles 520, 522 can be folded by retracting the actuationshaft or means of actuating 512 of the third catheter 2208 relative tothe outer shaft 2220 of the third catheter 2208 and/or by advancing theouter shaft 2220 relative to the actuation shaft or means of actuating512, causing the paddles 520, 522 to bend from the configuration shownin FIG. 153, to the configuration shown in FIG. 154, and then to theconfiguration shown in FIG. 155. This can be accomplished, for example,by placing the actuation lock mechanism 2248 in the releaseconfiguration (e.g., by rotating the knob 2288 counterclockwise relativeto the handle 2222) and then moving the knob 2226 proximally relative tothe housing 2246. Another option is to set the locking knob 2288 tomaintain enough friction that you can actively slide the actuation wireor shaft 512 but the actuation wire or shaft will not move on its own.At any point in the procedure, the physician can lock the relativeposition of the actuation shaft or means of actuating 512 and the outershaft 2220, and thus the position of the paddles 520, 522, by actuatingthe actuation locking mechanism 2248.

The prosthetic spacer device 500 can then be positioned coaxial relativeto the native mitral valve MV by manipulating (e.g., steering and/orbending) the second sheath 2218 of the second catheter 2206, as shown inFIG. 155. The prosthetic spacer device 500 can also be rotated (e.g., byrotating the housing 2246) relative to the native mitral valve MV suchthat the paddles 520, 522 align with native leaflets 20, 22 of themitral valve MV.

The paddles 520, 522 of the prosthetic spacer device 500 can then bepartially opened (i.e., moved radially outwardly relative to thecoaption element 510) to the configuration shown in FIG. 156 by movingthe knob 2226 distally relative to the housing 2246. The prostheticspacer device 500 can then be advanced through the annulus of the nativemitral valve MV and at least partially into the left ventricle LV. Theprosthetic spacer device 500 is then partially retracted such that thepaddles 520, 522 are positioned behind the ventricular portions of theleaflets 20, 22 (e.g., at the A2/P2 positions) and the coaption element510 is disposed on the atrial side of the leaflets 20, 22.

In this configuration, the native leaflets 20, 22 can be securedrelative to the paddles 520, 522 by capturing the native leaflets withthe clasps 530. The native leaflets 20, 22 can be grasped simultaneouslyor separately by actuating the actuator member 2290. For example, FIG.157 shows separate leaflet grasping. This can be accomplished byremoving the pin 2298 from the actuator member 2290 and moving the firstor second side portions 2294, 2296 relative to each other, the knob2226, and the housing 2246. Moving the first or second side portions2294, 2296 distally relative to the knob 2226 and the housing 2246closes the clasps 530 on the native leaflets 20, 22 (e.g., as shown bythe left clasp 530 as illustrated in FIG. 157). Moving the first orsecond side portions 2294, 2296 proximally relative to the knob 2226 andthe housing 2246 opens the clasps 530 (e.g., as shown by the right clasp530 as illustrated in FIG. 157). Once a clasp 530 is closed, a physiciancan re-open the clasp 530 to adjust the positioning of the clasp 530.

With both of the native leaflets 20, 22 secured within the clasps 530,the physician can move the knob 2226 proximally relative to the housing2246. This pulls the paddles 520, 522 and thus the native leaflets 20,22 radially inwardly against the coaption element 510, as shown in FIG.158. The physician can then observe the positioning and/or reduction inregurgitation. If repositioning or removal is desired the physician canre-open the paddles 520, 522 and/or the clasps 530.

Once the desired positioning and/or reduction in regurgitation isachieved, the physician can release the prosthetic spacer device 500from the delivery apparatus 2202. The clasps 530 can be released fromthe delivery apparatus 2202 by releasing the clasp control members 537from the locking members 2292 and unthreading the clasp control members537 from the openings 535 of the clasps 530. The cap 514 of theprosthetic spacer device 500 can be released from the delivery apparatus2202 by rotating the knob 2226 in the second direction relative to thehousing 2246 such that the actuation shaft or means of actuating 512withdraws from the bore 516A. The actuation shaft or means of actuating512 can then be retracted proximally through the prosthetic spacerdevice 500 by pulling the knob 2226 proximally relative to the housing2224. The proximal collar 511 of the prosthetic spacer device 500 can bereleased from the delivery apparatus 2202 by retracting the actuationshaft or means of actuating 512 proximally relative to the coupler ormeans for coupling 2214 such that the distal end portion of theactuation shaft or means of actuating 512 withdraws from the eyelets2234 of the coupler or means for coupling 2214. This allows the flexiblearms 2228 of the coupler or means for coupling 2214 to move radiallyoutwardly away from the projections 511A of the proximal collar 511. Thestabilizer members 2230 of the coupler or means for coupling 2214 canthen be withdrawn from the guide openings 511B of the proximal collar511 by pulling the housing 2246 proximally, thereby releasing theprosthetic spacer device 500 from the delivery apparatus 2202 as shownin FIG. 159.

The shafts 512, 2220 of the third catheter 2208 can then be retractedproximally into the second sheath 2218 of the second catheter 2206, andthe second sheath 2218 of the second catheter 2206 can be retractedproximally into the first sheath 2216 of the first catheter 2204. Thecatheters 2204, 2206, 2208 can then be retracted proximally and removedfrom the patient's vasculature.

With the prosthetic spacer device 500 implanted at the A2/P2 position,the native mitral valve MV comprises a double orifice during ventriculardiastole, as shown in FIG. 160. During ventricular systole, the sidesurfaces of the native leaflets 20, 22 can coapt all the way around theprosthetic spacer device 500 to prevent or reduce mitral regurgitation.

Referring now to FIGS. 161-162, an exemplary embodiment of a handle 2300for the delivery apparatus 2200 is shown. Referring to FIG. 161, thehandle 2300 can comprise a housing 2302, an actuation control mechanism2304, the clasp control mechanism 2250, and a flushing mechanism (notshown, but see, e.g., the flushing mechanism 2252 in FIG. 150). Thehousing 2302 can include a main body 2306 and the nose portion 2256. Thenose portion 2256 of the housing 2302 can be coupled to a proximal endportion of the outer shaft 2220. The actuation control mechanism 2304,the clasp control mechanism 2250, and a flushing mechanism 2252 can becoupled to a proximal end of the main body 2306 of the housing 2302.

The handle 2300 can be configured similar to the handle 2222, exceptthat the handle 2300 is configured such that rotational movement of thefirst knob 2318 of the actuation control mechanism 2304 relative to thehousing 2302 causes axial movement of the actuation tube 2268 and theactuation shaft or means of actuating 512; whereas, the handle 2222 isconfigured such that axial movement of the knob 2226 relative to thehousing 2246 causes axial movement of the actuation tube 2268 and theactuation shaft or means of actuating 512.

As mentioned above, the housing 2302 can include a main body 2306 andthe nose portion 2256. Referring to FIG. 162, the main body 2306 of thehousing 2302 can comprise an actuation lumen 2308, control member lumens2310, and a flange portion 2312. The flange portion 2312 can extendaxially from a proximal end portion of the main body 2306 and annularlyaround the actuation lumen 2308.

The flange portion 2312 of the main body 2306 can comprise one or morecircumferential grooves 2314, a bore (not shown), and a guide pin 2316.The grooves 2314 can be configured to interact with the actuationcontrol mechanism 2304, as further described below. The bore can extendradially inwardly from an outside diameter to an inside diameter of theflange portion 2312 and can be configured to receive the guide pin 2316.The guide pin 2316 can be partially disposed in the bore and can extendradially inwardly from the bore such that the guide pin 2316 protrudesinto the actuation lumen 2308.

Referring still to FIG. 162, the actuation control mechanism 2304 cancomprise a first knob 2318, attachment pins 2320, a drive screw 2322, acollet 2324, and a second knob 2326. The first knob 2318 can have adistal end portion 2328 and a proximal end portion 2330. The first knob2318 can be configured such that the inside diameter of the distal endportion 2328 is relatively larger than the inside diameter of theproximal end portion 2330. The distal end portion 2328 can compriseopenings 2332 that extend radially inwardly from an outside diameter tothe inside diameter of the distal end portion 2328.

Referring again to FIG. 161, the inside diameter of the distal endportion 2328 can be configured such that the distal end portion 2328 ofthe first knob 2318 can extend over the flange portion 2312 of the mainbody 2306. The openings 2332 (FIG. 162) can be configured to axiallyalign with the grooves 2314 when the first knob 2318 is disposed overthe flange 2312. The attachment pins 2320 can be configured so as toextend through the openings 2332 of the first knob 2318 and into grooves2314 of the flange 2312. In this manner, the attachment pins 2320 allowrelative rotational movement and prevent relative axial movement betweenthe first knob 2318 and the flange 2312.

The inside diameter of the proximal end portion 2330 of the first knob2318 can have internal threads (not shown) configured to engagecorresponding external threads 2334 of the drive screw 2322. As shown inFIG. 162, the drive screw 2322 can have a slot 2336 that extends axiallyacross the external threads 2334. The slot 2336 can be configured toreceive the guide pin 2316 of the flange portion 2312. As such, when thehandle 2300 is assembled (FIG. 161) and the first knob 2318 is rotatedrelative to the flange 2316, the guide pin 2316 prevents the drive screw2322 from rotating together with the first knob 2318 and causes thedrive screw 2322 to move axially relative to the first knob 2318 and theflange 2316. In this manner, rotating the first knob 2318 in a firstdirection (e.g., clockwise) moves the drive screw distally relative tothe housing 2306, and rotating the first knob 2318 in a second direction(e.g., counterclockwise) moves the drive screw proximally relative tothe housing 2306.

The drive screw 2322 can also have a lumen 2338, as shown in FIG. 162.The lumen 2338 can be configured such that the actuation tube 2268 canextend through the drive screw 2322. The lumen 2338 can be configuredsuch that a distal end portion 2340 of the collet 2324 can also beinserted into a proximal end portion of the lumen 2338.

The second knob 2326 can comprise a first, distal portion 2342 and asecond, proximal portion 2344. The first portion 2342 can includeinternal threads (not shown) corresponding to the external threads 2334of the drive screw 2322. The second portion 2344 can comprise a conicalinside surface configured to engage a proximal end portion 2346 of thecollet 2324.

When assembled (FIG. 161), the actuation tube 2268 can extend throughthe lumen 2338 of the drive screw 2322, through the collet 2324, andthrough the second knob 2326. The second knob 2326 can be disposed overthe collet 2324 and the internal threads of the first portion 2342 ofthe second knob can threadably engage the external threads 2334 of thedrive screw 2322. Accordingly, rotating the second knob 2326 in a firstdirection (e.g., clockwise) relative to the drive screw 2322 causes thesecond portion 2344 of the second knob 2326 to move toward the proximalend portion 2346 of the collet 2324 and thus urges the collet 2324radially inwardly against the actuation tube 2268. As a result, theactuation tube 2268 and the drive screw 2322 move axially together whenthe first knob 2318 is rotated relative to the housing 2306. Rotatingthe second knob 2326 in a second direction (e.g., counterclockwise)relative to the drive screw 2322 causes the second portion 2344 of thesecond knob 2326 to move away from the proximal end portion 2346 of thecollet 2324 and thus allows the collet 2324 to move radially outwardlyrelative to the actuation tube 2268. As a result, the actuation tube2268 and the drive screw 2322 can move relative to each other.

With the prosthetic spacer device 500 coupled to the actuation shaft ormeans of actuating 512 and the outer shaft 2220 of the deliveryapparatus 2202, the physician can use the actuation control mechanism2304 of the handle 2300 to manipulate the paddles 520, 522 of theprosthetic spacer device 500 relative to the spacer member 202 of theprosthetic spacer device 500. The actuation control mechanism 2304 canbe activated by rotating the second knob 2326 in the first directionrelative to the drive screw 2322 to secure the actuation tube 2268 andthus the actuation shaft or means of actuating 512 to the drive screw2322. The physician can then rotate the first knob 2318 relative to thehousing 2302, which causes the drive screw 2322 and thus the actuationtube 2268 and the actuation shaft or means of actuating 512 to moveaxially relative to the housing 2302 and thus the outer shaft 2220.This, in turn, causes the paddles 520, 522 (which are coupled to theactuation shaft or means of actuating 512 via the cap 514) to moverelative to the coaption element 510 (which is coupled to the outershaft 2220 via coupler or means for coupling 2214 and the proximalcollar 511).

The prosthetic spacer device 500 can be released from the deliveryapparatus 2202 by rotating the second knob 2326 in the second directionrelative to the drive screw 2322. This allows the actuation tube 2268and thus the actuation shaft or means of actuating 512 to move relativeto the drive screw 2322. The shafts 512, 2220 of the delivery apparatus2202 can then be removed from the respective collars of the prostheticspacer device 500, as described above.

Configuring a delivery apparatus with the actuation control mechanism2304 can provide several advantages. For example, the rotational forcesrequired to actuate the first knob 2318 of the handle 2300 can be lessthan the axial forces required to actuate the knob 2226 of the handle2300.

The actuation control mechanism 2304 can also provide relatively moreprecise control of the paddles 520, 522 because the axial movement ofthe actuation shaft or means of actuating 512 is controlled by rotationof the first knob 2318 and the thread pitch of the drive screw 2322rather than be axial movement of the knob 2226. In other words, theactuation control mechanism 2304 can be configured, for example, suchthat one rotation of the first knob 2318 moves the actuation shaft ormeans of actuating 512 a small axial distance (e.g., 1 mm): whereas, itmay be relatively more difficult to axially move the knob 2226 and thusthe shaft 512 in small increments (e.g., 1 mm).

Additionally, the actuation control mechanism 2304 can prevent or reduceinadvertent movement and release of the actuation shaft or means ofactuating 512. For example, because the actuation control mechanism 2304requires rotational movement of the first knob 2318 to move theactuation shaft or means of actuating 512, it can prevent or reduce thelikelihood that the actuation shaft or means of actuating 512 will moveif the knob 2226 is inadvertently contacted. Also, the physician has torotate the second knob 2326 to release the actuation tube 2268 from thedrive screw 2322 before the physician can rotate the knob 2226 torelease the actuation shaft or means of actuating 512 from the cap 514of the prosthetic spacer device 500 and proximally retract the actuationshaft or means of actuating 512. This two-step release process couldreduce the likelihood of a physician inadvertently releasing theprosthetic spacer device 500 from the delivery apparatus 2202.

FIGS. 163-164 show exemplary embodiments of a coupler 2400 and aproximal collar 2402. Although not shown, the coupler 2400 can becoupled to the distal end portion of the outer shaft 2220 (FIG. 149) ina manner similar to the coupler or means for coupling 2214. As shown,the proximal collar 2402 can be coupled to a proximal end portion of thecoaption element 510 in a manner similar to the proximal collar 511(FIG. 146). As such, the coupler 2400 and the proximal collar 2402 canbe used, for example, in lieu of the coupler or means for coupling 2214and the proximal collar 514 of the delivery assembly 2200, respectively,to releasably couple the prosthetic spacer device 500 to the outer shaft2220 (FIG. 149).

Referring to FIG. 164, the coupler 2400 can comprise anaxially-extending lumen 2404 and a plurality of radially-extendingopenings 2406. The lumen 2404 can be configured to receive the actuationshaft or means of actuating 512 (FIG. 163). The openings 2406 can beconfigured to receive the proximal collar 2402, as further describedbelow.

The proximal collar 2402 can comprise a plurality ofproximally-extending tabs or fingers 2408. Free end portions 2410 of thefingers 2408 can have radially-extending projections 2412 formedthereon. The fingers 2408 can be configured to pivot between a first orresting state (FIG. 164) and a second or deflected state (FIG. 163). Inthe first state, the free end portions 2410 of the fingers 2408 pressradially inwardly against each other. In the second state, the free endportions 2410 of the fingers 2408 are radially spaced from each other.

Referring to FIG. 163, the coupler 2400 and the proximal collar 2402 bereleasably coupled together by positioning the fingers 2408 of theproximal collar 2402 within the coupler 2400. The actuation shaft ormeans of actuating 512 can then be advanced through the lumen 2404 ofthe coupler 2400 and through the fingers 2408 of the proximal collar2400, thus causing the free ends 2410 of the fingers 2408 to pivotradially-outwardly from the first state to the second state. Theprojections 2412 of the fingers 2408 and the openings 2406 of thecoupler 2400 can be rotationally aligned such that the projections 2412extend into the openings 2406, thereby releasably coupling the coupler2400 to the proximal collar 2402. The coupler 2400 can be released fromthe proximal collar 2402 by retracting the actuation shaft or means ofactuating 512 from the finger 2408 of the proximal collar 2402. Thisallows the free end portions 2410 of the fingers 2408 to pivot from thesecond state back to the first state and causes the projections 2412 ofthe fingers 2408 to withdraw from the openings 2406 of the coupler 2402,thus releasing the coupler 2400 from the proximal collar 2402.

In some embodiments, the fingers 2408 of the proximal collar 2402 can beconfigured to create a hemostatic seal when the fingers 2408 are in thefirst state. This can, for example, prevent or reduce blood from flowingthrough the proximal collar 2402 when the prosthetic spacer device 500is implanted in a patient.

FIGS. 165-166 show exemplary embodiments of a cap 2500, an actuationshaft or means of actuating 2502, and a release member (e.g., wire)2504, which can be used, for example, with the delivery assembly 2200.Although not shown, the cap 2500 can be coupled to the distal portion ofthe prosthetic spacer device 500. A proximal portion (not shown) of theactuation shaft or means of actuating 2502 can be coupled to theactuation tube 2268 and the knob 2226. From the proximal end portion,the actuation shaft or means of actuating 2502 can extend distallythrough the handle 2222 (FIG. 150), through the outer shaft 2220 (FIG.150), and into the prosthetic spacer device 500 (FIG. 145). A distal endportion of the actuation shaft or means of actuating 2502 can bereleasably coupled to the cap 2500 of the prosthetic spacer device 500.As such, the cap 2500 and the actuation shaft or means of actuating 2502can be used, for example, in lieu of the cap 514 and the actuation shaftor means of actuating 512 of the delivery assembly 2200, respectively.

Referring to FIG. 166, the cap 2500 can comprise a central bore 2506 anda tongue or tab 2508 formed (e.g., laser cut) in a side surface 2510 ofthe cap 2500. The tongue 2508 can have an opening 2512 formed (e.g.,laser cut) therein. The central bore 2506 can be configured to receive adistal end portion of the actuation shaft or means of actuating 2502.The tongue 2508 can be pivotable relative to the side surface 2508 ofthe cap 2500 from a first or resting configuration (FIG. 166) to asecond or deflected configuration (FIG. 165). In the firstconfiguration, the tongue 2508 can be flush with the side surface 2510.In the second configuration, the tongue 2508 can extend radiallyinwardly relative to the side surface 2510 to protrude into the centralbore 2506.

The tongue 2508 can be used, for example, to releasably couple the cap2500 to the actuation shaft or means of actuating 2502, as shown inFIGS. 165 and 166. For example, the actuation shaft or means ofactuating 2502 can be inserted into the central bore 2506 of the cap2500. The tongue 2508 can then be pushed radially inwardly from thefirst configuration to the second configuration such that the tongue2508 presses against the actuation shaft or means of actuating 2502. Therelease member 2504 can then be advanced distally such that a distal endportion 2514 of the release member 2504 extends through the opening 2512of the tongue 2508. Thus, the release member 2504 retains the tongue2508 in the second configuration against the actuation shaft or means ofactuating 2502, thereby releasably coupling the cap 2500 to theactuation shaft or means of actuating 2502.

The cap 2500 can be released from the actuation shaft or means ofactuating 2500 by retracting the release member 2504 proximally suchthat the distal end portion 2514 of the release member 2504 withdrawsfrom the opening 2512 of the tongue 2508. This allows the tongue to moveradially outwardly from the second state back to the first state,thereby releasing the cap 2500 from the actuation shaft or means ofactuating 2502.

This configuration can provide several advantages. For example, in someembodiments, the cap 2500 and the actuation shaft or means of actuating2502 can be formed without threads. Removing the threads can makemanufacturing the cap 2500 and the actuation shaft or means of actuating2502 easier and/or less expensive. Removing the threads from theactuation shaft or means of actuating 2502 can also reduce thelikelihood the actuation shaft or means of actuating 2502 could catch orsnag on another component of the delivery assembly 2200.

FIGS. 167-168 show exemplary embodiments of a coupler 2600, a proximalcollar 2602, a cap 2604, and an actuation shaft or means of actuating2606, which can be used, for example, with the delivery assembly 2200.Referring to FIG. 167, the coupler 2600 can be coupled to the distal endportion of the outer shaft 2220. The proximal collar 2602 can be coupledto the proximal portion of the prosthetic spacer device 500 (shownschematically in partial cross-section), and the cap 2604 can be coupledto the distal portion of the prosthetic spacer device 500. A proximalportion (not shown) of the actuation shaft or means of actuating 2606can be coupled to the actuation tube 2268 and the knob 2226. From theproximal end portion, the actuation shaft or means of actuating 2606 canextend distally through the handle 2222 (FIG. 150), through the outershaft 2220 (FIG. 150), and into the prosthetic spacer device 200 (FIG.145). A distal end portion of the actuation shaft or means of actuating2606 can be releasably coupled to the cap 2604 of the prosthetic spacerdevice 500. As such, the coupler 2600, the proximal collar 2602, the cap2604, and the actuation shaft or means of actuating 2606 can be used,for example, in lieu of the coupler or means for coupling 2214, theproximal collar 511, the cap 514, and the actuation shaft or means ofactuating 512 of the delivery assembly 2200, respectively.

Referring to FIG. 168, the coupler 2600 can comprise a connectionportion 2608, a plurality of pins 2610 (e.g., three in the illustratedembodiment), and one or more securing members 2612 (e.g., three in theillustrated embodiment). The pins 2610 and the securing members can becoupled to and extend distally from the connection portion 2600.

The connection portion 2608 can have an axially-extending lumen 2614configured to slidably receive the actuation shaft or means of actuating2606. In some embodiments, the connection portion 2608 can also have arecessed outwardly facing surface 2615 configured to be inserted intothe distal end portion of the outer shaft 2220, as shown in FIG. 167.

As best shown in FIG. 168, the pins 2610 can be spaced circumferentiallyrelative to each other and relative to the securing members 2612. Thesecuring members 2612 can be spaced circumferentially relative to eachother. In some embodiments, the pins 2610 and the securing members 2612can be configured in an alternating type pattern (e.g., pin-securingmember-pin and so on) on the connection portion 2608.

Referring to FIG. 167, the pins 2610 can be configured to extend intoopenings 2616 of the proximal collar 2602. In certain embodiments, thesecuring members 2612 can be suture loops. The securing members 2612 canbe configured to extend through the openings 2616 of the proximal collar2602 and around the actuation shaft or means of actuating 2606. Forclarity, only one securing member 2612 is shown extending around theactuation shaft or means of actuating 2606 in FIG. 167.

Referring again to FIG. 168, in addition to the openings 2616, theproximal collar 2602 can comprise a central lumen 2618 disposed radiallyinward from the openings 2616. The central lumen 2618 can extend axiallyand can be configured to slidably receive the actuation shaft or meansof actuating 2606, as shown in FIG. 167.

The cap 2604 can be configured in a sleeve-like manner such that theactuation shaft or means of actuating 2606 can slidably extend throughthe cap 2604, as shown in FIG. 167.

The actuation shaft or means of actuating 2606 can comprise aradially-expandable portion 2620 disposed at or near the distal endportion 2622 of the actuation shaft or means of actuating 2606. Theradially-expandable portion 2620 can be configured to be selectivelyexpandable from a compressed configuration to an expanded configuration.The radially-expandable portion 2620 can be configured such that anoutside diameter of the radially-expandable portion 2620 is less thanthe inside diameter of the cap 2604, the central lumen 2618 of theproximal collar 2602, and the lumen 2614 of the coupler 2600 when theradially-expandable portion 2620 is in the compressed configuration.When the radially expandable portion 2620 is in the expandedconfiguration, the outside diameter of the radially-expandable portion2620 is greater than the inside diameter of the cap 2604. Thus, in theexpanded configuration, the radially-expandable portion 2620 can preventthe distal end portion 2622 from moving proximally relative to the cap2604.

As shown in FIG. 167, the prosthetic spacer device 500 can be releasably coupled to the outer shaft 2220 and the actuation shaft or means ofactuating 2606 by inserting the pins 2610 and the securing members 2612through respective openings 2616 in the proximal collar 2602. With theradially-expandable portion 2620 in the compressed configuration, theactuation shaft or means of actuating 2606 can be advanced distallythrough the lumen 2614 of the coupler 2600, through the lumen 2618 andthe securing members 2612 of the proximal collar 2602, and through thecap 2604 such that the radially-expandable portion 2620 is disposeddistal relative to the cap 2604. The radially-expandable portion 2620 ofthe actuation shaft or means of actuating 2606 can then be expanded fromthe compressed configuration to the expanded configuration, thusreleasably coupling the prosthetic spacer device 500 to the outer shaft2220 and the actuation shaft or means of actuating 2606.

The prosthetic device 500 can be released from the outer shaft 2220 andthe actuation shaft or means of actuating 2606 by compressing theradially-expandable portion 2620 of the actuation shaft or means ofactuating 2606 and proximally retracting the actuation shaft or means ofactuating 2606 through the cap 2604, through the securing members 2612and the lumen 2618 of the proximal collar 2602. The outer shaft 2220 canthen be retracted proximally relative to the prosthetic spacer device500 such that the pins 2610 and the securing members 2612 withdraw fromthe openings 2616 in the proximal collar 2602, thus releasing theprosthetic spacer device 500 from the outer shaft 2220 and the actuationshaft or means of actuating 2606.

FIGS. 169-170 show an exemplary embodiment of clasp control members2700, which can be used, for example, in lieu of the clasp controlmembers 537 of the delivery assembly 2200. Referring to FIG. 170, theclasp control members 2700 can comprise sleeves 2702, connecting members2704, and release members 2706. The connecting members 2704 and therelease members 2706 can extend axially through and can be movablerelative to the sleeves 2702.

Proximal end portions (not shown) of the sleeves 2702 can be coupled tothe control member tubes 2270, and distal end portions of the sleeves2708 can be releasable coupled to the clasps 530 of the prostheticspacer device 500 by the connecting members 2704 and the release members2706, as further described below.

The connecting members 2704 can, for example, be suture loops thatextend distally from the clasp control mechanism 2250 of the deliveryapparatus 2202, through the control member tubes 2270, through thesleeves 2702, and through the openings 535 of the clasps 530. Theconnecting members 2704 can be releasably coupled to the clasps 530 theprosthetic spacer device 500 by the release members 2706.

The release members 2706 can, for example, be wires that extend distallyfrom the clasp control mechanism 2250 of the delivery apparatus 2202,through the control member tubes 2270, through the sleeves 2702, andthrough the loops of the connecting members 2704. In this manner, therelease members 2706 releasably couple the connecting members 2704 andthus the sleeves 2702 to the clasps 530 by preventing the connectionmembers 2704 from withdrawing through the openings 535 of the clasps530. The connection members 2704 can be released from the clasps 530 bywithdrawing the release members 2706 from the loops of the connectingmembers 2704 and withdrawing the connecting members 2704 from theopenings 535 of the clasps 530.

With the sleeves 2702 releasably coupled to the clasps 530 of theprosthetic spacer device 500 by the connecting members 2704 and therelease members 2706, the clasps 530 can be actuated (either together orseparately) by moving the sleeves 2702 axially relative to the outershaft 2220 and the actuation shaft or means of actuating 512. This canbe accomplished, for example, by moving the actuator member 2290, whichare coupled to the sleeves 2702 via the control tubes 2268, relative tothe housing 2246 and actuation tube 2268. Moving the actuation member2290 proximally relative to the housing 2246 and actuation tube 2268 canopen the clasps 530 and moving the actuation member 2290 distallyrelative to the housing 2246 and actuation tube 2268 can close theclasps 530.

Because the sleeves 2702 are relatively rigid (e.g., compared to theclasp control members 537), the sleeves 2702 can be used to push theclasps 530 closed (either in lieu of or in addition to the bias of theclasps 530 to the closed position). This pushability can help to ensurethe native leaflets are grasped within the clasps 530 and thus securedto the paddles 520, 522.

FIG. 171 shows an exemplary embodiment of a guide rail or means forguiding 2800. The guide rail or means for guiding 2800 can, for example,be coupled to the clasps 530 of the prosthetic spacer device 500. Insome embodiments, the clasp control member 2700 can be releasablycoupled to the guide rail or means for guiding 2800 in a snare-likemanner similar to that described above with respect to FIG. 170.

Coupling a clasp control member 2700 to the guide rail or means forguiding 2800 rather than directly to the clasps 530 allows the claspcontrol member 2700 to slide longitudinally along the guide rail ormeans for guiding 2800 as the clasp 530 moves between the open and theclosed configurations. This can, for example, allow the clasp controlmember 2700 to maintain a relatively constant angle relative to thepaddles 520, 522 as the clasps 530 are actuated. For example, the claspcontrol member 2700 can slide outwardly toward a first side portion 2802of the guide rail or means for guiding 2800 when the clasp 206 is pulledopen, and the clasp control member 2700 can slide inwardly toward asecond side portion 2804 of the guide rail or means for guiding 2800when the clasp 530 is pushed closed. This can therefore reduce the forcerequired to actuate the clasp control member 2700. For example, thesleeves 2702 can remain more substantially straight as the movableportion of the clasp 530 swings through its full arc of motion. This isdue to the sliding movement on the guide rail or means for guiding 2800.By sliding and remaining substantially straight, the amount of bendingof the sleeves is limited.

FIG. 172 shows an exemplary embodiment of a shaft 2900. The shaft 2900can be used, for example, with the delivery apparatus 500 in lieu of theouter shaft 2220 of the third catheter 508. The shaft 2900 can comprisea plurality of axially extending lumens, including an actuation shaft ormeans of actuating lumen 2902 and a plurality of control member lumens2904 (e.g., four in the illustrated embodiment) disposed radiallyoutwardly from the actuation shaft or means of actuating lumen 2902. Thecontrol member lumens 2904 can be spaced relative to each other and canbe evenly distributed circumferentially around the actuation shaft ormeans of actuating lumen 2902. For example, each of the control memberlumens 2904 can be located approximately 90 degrees from an adjacentcontrol member lumen 2904.

The actuation shaft or means of actuating lumen 2902 can be configuredto receive the actuation shaft or means of actuating 512, and thecontrol member lumens 2904 can be configured to receive the claspcontrol members 537. The lumens 2902, 2904 can also be configured suchthat the actuation shaft or means of actuating 512 and clasp controlmembers 537 can be movable (e.g., axially and/or rotationally) relativeto the lumens 2902, 2904, respectively. In particular embodiments, thelumens 2902, 2904 can comprise a liner or coating (e.g., PTFE)configured to reduce friction between the lumens 2902, 2904 and theactuation shaft or means of actuating 512 and clasp control members 537,respectively.

The shaft 2900 can be formed from various materials, including metalsand polymers. For example, in one particular embodiment, the shaft 2900can comprise a first portion 2906, a second portion 2908, and a thirdportion 2910. The first portion 2906 be the radially outermost portion,the third portion 2910 can be the radially innermost portion, and thesecond portion 2908 can be disposed radially between the first and thirdportions 2906, 2910. In certain embodiments, the first and thirdportions 2906, 2910 can be formed from polymeric material (e.g., PEBAXor other material having a Type D Shore durometer value of SSD), and thesecond portion 2908 can be formed from a metallic material (e.g.,braided stainless steel).

Configuring the shaft 2900 in this manner can, for example, furtherimprove control of the distal end portion of the shaft 2900. Forexample, this configuration can prevent or reduce “whipping” (e.g.,sudden or abrupt movement) at the distal end portion of the shaft 2900when the shaft 2900 is rotated at the proximal end portion (e.g., byrotating the housing 2246 of the handle 2222). As such, a physician canmore precisely control the distal end portion of the shaft 2900 and thusmore precisely control the prosthetic spacer device (e.g., the spacerdevice 500) during the implantation procedure such as when the physicianrotates the prosthetic spacer device to align the anchors of theprosthetic spacer device with the native leaflets.

It should be noted that in certain embodiments the housing 2246 of thehandle 2222 can comprise four control member lumens 2264, 2282 (i.e.,four of each) that are coupled to the control member lumens 2904. Assuch, each portion of the clasp control members 537 can extend distallyin a separate lumen from the clasp control mechanism 2250 of the handle2222 to the prosthetic spacer device 500.

Referring to FIG. 173, the actuation wire 512 can be hollow so that atethering line or suture 3000 can be extended through the actuation wire512 to the device 500. The actuation wire 512 extends through the device500 and is attached to the cap 514. Retracting the tethering line 3000in the retraction direction X relative to a coupler of the deliveryassembly 2200 reduces the length of the tethering line 3000, therebymoving the coupler of the delivery assembly 2200 toward the device 500in a recapture direction Y.

Referring again to FIG. 173, the device 500 is shown in a closedposition having been delivered and implanted in the native mitral valve.Once the device 500 is implanted, the coupler of the delivery assembly2200 is opened and moved away from the device in a retraction directionX so that the performance of the device 500 can be monitored to see ifany adjustments may be desirable. If further adjustments to the device500 are desired, the tethering line 3000 is retracted in the retractiondirection X so that the coupler of the delivery assembly 2200 moves inthe recapture direction Y toward the device 500.

Referring now to FIG. 174, the coupler of the delivery assembly 2200 hasbeen moved into a suitable position to recapture the device 500. Once inposition, the actuation lines 3002 for each moveable arm 2228 areretracted in an actuation direction A to cause the moveable arms 2228 tomove in a closing direction B close around the proximal collar 511 ofthe device 500. In some embodiments, the tethering line 3000 is adjustedsimultaneously with the actuation lines 3002 to aid in recapturing thedevice 500 which may be moving around as the native mitral valve MVopens and closes.

Referring now to FIG. 175, the moveable arms 2228 are closed around theproximal collar 511. The actuation wire 512 is then moved in a distaldirection C, through the securing portions 2234 of the moveable arms2228 and into the device 500 along the tethering line 3000. To recaptureand secure the device 500, a threaded end 512B of the actuation wire 512is threaded into a threaded receptacle 516A of the cap 514 as shown inFIG. 176.

FIGS. 174A and 175A illustrate another example of a mechanism that canbe used to recouple the coupler of the delivery assembly 2200 to thecollar 511 of the device 500. In the example of FIGS. 174A and 175A, theactuation wire 512 can be hollow so that a tethering line or suture 3000can be extended through the actuation wire 512 to the device 500. As inthe embodiment illustrated by FIGS. 174 and 175, retracting thetethering line 3000 in the retraction direction X moves the coupler ofthe delivery assembly 2200 toward the device 500 in a recapturedirection Y.

Referring now to FIG. 174A and 175A, the coupler of the deliveryassembly 2200 has been moved into a suitable position to recapture thedevice 500. Once in position, a closing sleeve 3003 that fits around themoveable arms 2228 is advanced over the coupler of the delivery assembly2200 in a closing direction C to press the moveable arms 2228 inward ina closing direction D around the proximal collar 511 of the device 500.In some embodiments, the tethering line 3000 is adjusted simultaneouslywith the closing sleeve 3003 to aid in recapturing the device 500 whichmay be moving around as the native mitral valve MV opens and closes.

Referring now to FIG. 175A, the moveable arms 2228 are closed around theproximal collar 511. The actuation wire 512 is then moved in a distaldirection E and into the device 500 along the tethering line 3000. Torecapture and secure the device 500, a threaded end 512B of theactuation wire 512 is threaded into a threaded receptacle 516A of thecap 514 as shown in FIG. 176.

Referring now to FIGS. 177-178, an exemplary implantable prostheticdevice 3100 is shown. The device 3100 includes an implantable prostheticdevice 3110 and a coupler 3120. An actuation shaft or means of actuatingor wire 3130 can extend through the coupler 3120 to the device 3110 toopen and close the device 3110. The device 3110 is similar to exemplaryimplantable prosthetic devices described in the present application andincludes a proximal collar 3112 having an opening 3114 and radiallydisposed apertures 3116. The coupler 3120 has moveable arms or fingers3122 that can be moved between open and closed positions. The moveablearms 3122 include protrusions 3124 configured to engage the apertures3116 of the proximal collar 3112 of the device 3110. The moveable arms3122 are biased inward so that moving the actuation shaft or means ofactuating 3130 in a distal direction Y through the coupler 3120 andbetween the moveable arms 3122 spreads the moveable arms 3122 outwardsso that the protrusions 3124 engage the apertures 3116. In theillustrated embodiment, the protrusions 3124 and apertures 3116 aretapered to ease engagement of the protrusions 3124 with the apertures3116. Moving the actuation shaft or means of actuating 3130 in aretraction direction X allows the moveable arms 3122 to move inward sothat the protrusions 3124 disengage the apertures 3116. In this way thedevice 3110 can be released and recaptured by the coupler 3120.

Referring now to FIGS. 179-181, an exemplary implantable prostheticdevice 3200 is shown. The device 3200 includes an implantable prostheticdevice 3210 and a coupler 3220. An actuation shaft or means of actuatingor wire 3230 can extend through the coupler 3220 to the device 3210 toopen and close the device 3210. The device 3210 is similar to exemplaryimplantable prosthetic devices described in the present application andincludes a proximal collar 3212 having an opening 3214 and radiallydisposed apertures 3216.

The coupler 3220 has moveable arms or fingers 3222 that can be movedbetween open and closed positions. The moveable arms 3222 includeprotrusions 3224 configured to engage the apertures 3216 of the proximalcollar 3212 of the device 3210. The moveable arms 3222 are biased inwardso that moving the actuation shaft or means of actuating 3230 in adistal direction Y through the coupler 3220 and between the moveablearms 3222 spreads the moveable arms 3222 outwards so that theprotrusions 3224 engage the apertures 3216. Moving the actuation shaftor means of actuating 3230 in a retraction direction X allows themoveable arms 3222 to move inward so that the protrusions 3224 disengagethe apertures 3216. In this way the device 3210 can be released andrecaptured by the coupler 3220.

The actuation wire 3230 can be hollow so that a tethering line or suture3232 can be extended through the actuation wire 3230 to the device 3210.The actuation wire 3230 extends through the opening 3214 of the device3210 and is attached to securing portions 3218. Retracting the tetheringline 3232 in the retraction direction X (FIG. 180) reduces the length ofthe tethering line 3232, thereby moving the coupler 3220 toward thedevice 3210 such that the moveable arms 3222 are inserted into theopening 3214 of the device 3210 as shown in FIG. 180.

Referring now to FIG. 181, once the coupler 3220 has been moved intoposition to recapture the device 3210 the actuation wire 3230 is movedin the distal direction Y to recouple the coupler 3220 to the device3210. The actuation wire 3230 engages the moveable arms 3222, therebycausing the protrusions 3224 to move in an outward direction A to engagethe apertures 3216 of the device 3210. In the illustrated embodiment,the protrusions 3224 and apertures 3216 are tapered to ease engagementof the protrusions 3224 with the apertures 3216. In some embodiments,the tethering line 3232 is adjusted simultaneously as the actuationshaft or means of actuating 3230 is extended to take up slack in theactuation line and maintain engagement between the coupler 3220 anddevice 3210.

Referring now to FIGS. 182-183, an exemplary implantable prostheticdevice 3300 is shown. The device 3300 includes an implantable prostheticdevice 3310 and a coupler 3320. An actuation shaft or means of actuatingor wire 3330 can extend through the coupler 3320 to the device 3310 toopen and close the device 3310. The device 3310 is similar to exemplaryimplantable prosthetic devices described in the present application andincludes a proximal collar 3312 having an opening 3314 and radiallydisposed apertures 3316.

The coupler 3320 has moveable arms or fingers 3322 that can be movedbetween open and closed positions. The moveable arms 3322 include distalprotrusions 3324 configured to engage the apertures 3316 of the proximalcollar 3312 of the device 3310. The moveable arms 3324 also includeinternal protrusions 3326 having apertures 3328 configured to receivethe actuation shaft or means of actuating 3330. In the closed position,the internal apertures 3328 are offset from the actuation shaft or meansof actuating 3330. The actuation shaft or means of actuating 3330 has atapered end 3332 to engage the offset apertures 3328. As successiveapertures 3328 are engaged by the tapered end 3332 of the actuationshaft or means of actuating 3330, the moveable arms 3322 are movedoutward to engage the opening 3314.

The moveable arms 3322 are biased inward so that moving the actuationshaft or means of actuating 3330 in a distal direction Y through thecoupler 3320 and between the moveable arms 3322 spreads the moveablearms 3322 outwards so that the protrusions 3324 engage the apertures3316. Moving the actuation shaft or means of actuating 3330 in aretraction direction X allows the moveable arms 3322 to move inward sothat the protrusions 3324 disengage the apertures 3316. In this way thedevice 3310 can be released and recaptured by the coupler 3320. In someembodiments, the prosthetic device 3300 is similar to the device 3200and includes a tethering line (not shown) that allows the device 3300 tobe recaptured.

Referring now to FIGS. 184-185, an exemplary implantable prostheticdevice 3400 is shown. The device 3400 includes an implantable prostheticdevice 3410 and a coupler 3420. An actuation shaft or means of actuatingor wire 3430 can extend through the coupler 3420 to the device 3410 toopen and close the device 3410. The device 3410 is similar to exemplaryimplantable prosthetic devices described in the present application andincludes a proximal collar 3412 having an opening 3414 and radiallydisposed apertures 3416.

The coupler 3420 has moveable arms or fingers 3422 that can be movedbetween open and closed positions. The moveable arms 3422 include distalprotrusions 3424 configured to engage the apertures 3416 of the proximalcollar 3412 of the device 3410. The moveable arms 3424 also includeinternal protrusions 3426 having apertures 3428 configured to receivethe actuation shaft or means of actuating 3430. In the closed position,the internal apertures 3428 are offset from the actuation shaft or meansof actuating 3430. The actuation shaft or means of actuating 3430 has atapered end 3432 to engage the offset apertures 3428. As successiveapertures 3428 are engaged by the tapered end 3432 of the actuationshaft or means of actuating 3430, the moveable arms 3422 are movedinward to engage the opening 3414.

The moveable arms 3422 are biased outward so that moving the actuationshaft or means of actuating 3430 in a distal direction Y through thecoupler 3420 and between the moveable arms 3422 retracts the moveablearms 3422 inwards so that the protrusions 3424 engage the apertures3416. Moving the actuation shaft or means of actuating 3430 in aretraction direction X allows the moveable arms 4622 to spread outwardso that the protrusions 3424 disengage the apertures 3416. In this waythe device 3410 can be released and recaptured by the coupler 3420. Insome embodiments, the prosthetic device 3400 is similar to the device3200 and includes a tethering line (not shown) that allows the device3400 to be recaptured.

Referring to FIG. 186, an actuation shaft or means of actuating 3500 forplacing and actuating an implantable prosthetic device is shown. Theactuation shaft or means of actuating 3500 includes a hollow positioningshaft 3510 and a hollow device shaft 3520 that fit over a retainingshaft 3530 that holds the hollow positioning and device shafts 3510,3520 together at a connection 3502. The hollow positioning shaft 3510extends from a delivery device 3504 and when coupled to the device shaft3520 allows an implantable device 3506 to be placed in a suitablelocation for implantation. The location of the connection 3502 betweenthe hollow positioning shaft 3510 and the device shaft 3520 can be at awide variety of different positions in an implantable device. Forexample, the connection 3502 may at a proximal portion of a device ormay be at a distal portion of a device.

The hollow positioning shaft 3510 can include a protruding portion 3512and a recessed receiving portion 3514. The device shaft 3520 can alsoinclude a protruding portion 3522 and a recessed receiving portion 3524.When the hollow positioning and device shafts 3510, 3520 are coupled,the protruding portion 3512 of the hollow positioning shaft 3510 isreceived by the receiving portion 3524 of the device shaft 3520, and theprotruding portion 3522 of the device shaft 3520 is received by thereceiving portion 3514 of the hollow positioning shaft 3510.

The hollow positioning and device shafts 3510, 3520 can be connected ina wide variety of different ways. For example, the hollow positioningshaft 3510 can include a bore or channel 3516 that is aligned with abore or channel 3526 of the hollow device shaft 3520 when the protrudingportions 3512, 3522 are disposed in the receiving portions 3514, 3524,respectively. When the openings 3516, 3526 are aligned and the retainingshaft 3530 is placed into the openings 3516, 3526 in the direction X,the hollow positioning and device shafts 3510, 3520 are retainedtogether. When the retaining shaft 3530 is removed from the openings3516, 3526 in the direction Z, protruding portions 3512, 3522 can beremoved from the receiving portions 3514, 3524, such that the device3506 is detached from the hollow positioning shaft 3510.

Still referring to FIG. 186, in some embodiments, when the hollowpositioning and device shafts 3510, 3520 are secured to each other, anaperture 3540 is created at interface 3542 between the hollowpositioning and device shafts 3510, 3520. The aperture 3540 isconfigured to secure a control line 3544 between the hollow positioningand device shafts 3510, 3520 to allow for separate control of clasps orgripping members (not shown). That is, the aperture 3540 is configuredsuch that the line 3544 does not move relative to the aperture 3540 whenthe hollow positioning and device shafts 3510, 3520 are joined together.Upon detachment of the hollow positioning and device shafts 3510, 3520,the line 3544 is released from the aperture 3540 and can be removed fromthe implantable device 3506. The line 3544 can then be retracted intothe catheter to release the clasps gripping members.

Referring now to FIG. 187, an actuation or control mechanism 3600 isshown. The control mechanism 3600 can be used to open and close firstand second clasps or gripping members 3610, 3620 to grasp nativeleaflets for implantation of an implantable prosthetic device. Thecontrol mechanism 3600 includes a first gripper control member 3612 anda second gripper control member 3622. The first gripper control member3612 is configured to move the first gripping member 3610bi-directionally in the direction X, and the second gripper controlmember 3622 is configured to move the first gripping member 3620bi-directionally in the direction Z. Movement of the first grippingmember 3610 in the direction X adjusts the width W of a first opening3616 between the first gripping member 3610 and a first paddle 3614, andmovement of the second gripping member 3620 in the direction Z willadjust the width H of a second opening 3626 between the second grippingmember 3620 and a second paddle 3624.

In the illustrated embodiment, the gripper control members 3610, 3620include a push/pull link 3611, 3621, such as, for example, a catheter, aflexible rod, or a stiff wire and a coupler 3613, 3623. Each push/pulllink 3611, 3621 extends from a delivery device 3602 and is removablyattached to the corresponding gripping member 3612, 3622 by the couplers3613, 3623. The link 3611 is configured to be pushed and pulled in thedirection Y. Movement of the link 3611 in the direction Y causes thegripping member 3610 to move in the direction X. Similarly, the link3621 is configured to be pushed and pulled in the direction M, andmovement of the link 3621 in the direction M causes the gripping member3620 to move in the direction H.

Referring now to FIGS. 188 and 188A, an actuation or control mechanism3700 for use in implantable prosthetic devices, such as the devicesdescribed in the present application, is shown. The actuation mechanism3700 allows for pushing and pulling of portions of an implantabledevice, such as the clasps or gripping members described above. Themechanism 3700 includes first and second control members 3710, 3720 thatextend from a delivery device 3702. The delivery device 3702 may be anysuitable device, such as a sheath or catheter. The first and secondcontrol members 3710, 3720 include first and second sutures 3712, 3722and first and second flexible wires 3714, 3724. The first and secondflexible wires 3714, 3724 extend from the delivery device 3702 and eachinclude a loop 3716, 3726 for receiving the first and second sutures3712, 3722 and for engaging a clasp or gripping member. Each of thefirst and second sutures 3712, 3722 extends from the delivery device3702, through a one of the first and second loops 3716, 3726,respectively, and back into the delivery device 3702. In the exampleillustrated by FIG. 188, each suture 3712, 3722 extends through one ofthe loops 3716, 3726 once. In the example illustrated by FIG. 188, eachsuture 3712, 3722 extends through one of the loops 3716, 3726 twice. Insome embodiments, the first and second control members 3712, 3722 extendthrough separate delivery devices 3702. The sutures 3712, 3722 areremovably attached to moveable arms of exemplary barbed clasps describedabove. The first and second loops 3716, 3726 of the respective wires3714, 3724 are able to move along the corresponding sutures 3712, 3722such that the loops 3716, 3726 can engage the corresponding barbedclasps to engage the moveable arms. That is, the sutures 3712, 3722 areused to pull the moveable arms in an opening direction and the wires3714, 3724 are used to push the moveable arms in a closing direction.The wires 3714, 3724 can be made of, for example, steel alloy,nickel-titanium alloy, or any other metal or plastic material. Incertain embodiments, the wires 3714, 3724 can have a diameter betweenabout 0.10 mm and about 0.35 mm, between about 0.15 mm and about 0.30mm, and between about 0.20 mm and about 0.25 mm. While the wires 3714,3724 are shown as coming out of separate lumens than the sutures 3712,3722, in another embodiment, the wires 3714, 3724 can share a lumen witha suture.

In the examples of FIGS. 188 and 188A, the wires 3714, 3724 can bereplaced with a rigid or semi-rigid tube or pushable coil. The tube orpushable coil can share a lumen with a suture loop, the suture loop canbe disposed inside the tube or pushable coil. The tube or pushable coilcan be advanced over one side or both sides of each suture loop to push.The tube, pushable coil, or wire can be retracted as necessary into thecatheter when not needed.

Referring now to FIG. 189, another exemplary embodiment of an actuationor control mechanism 3800 includes a first catheter 3811, a secondcatheter 3821, and single line 3830, such as a wire or suture. The firstcatheter 3811 and line 3830 are configured to move a first grippingmember 3810 in the direction X, and the second catheter 3821 and line3830 configured to move a second gripping member 3820 in the directionZ. Movement of the gripping member 3810 in the direction X will adjustthe width W of a first opening 3816 between the first gripping member3810 and a first paddle 3814, and movement of the second gripping member3820 in the direction Z will adjust the width H of a second opening 3826between the second gripping member 3820 and a second paddle 3824. Theline 3830 extends from a delivery device 3802 through the catheters3811, 3821 and is threaded through openings in both gripping member3810, 3820. Each catheter 3811, 3821 is configured to engage and movethe corresponding gripping member 3810, 3820. In particular, the firstcatheter 3811 is configured to be pushed in the direction Y while theline 3830 is payed out of the second catheter 3821 or tension in theline 3830 is reduced. The first catheter 3811 is configured to be pulledin the direction Y while the line 3830 is pulled into the first catheter3811 or tension in the line is increased. Movement of the first catheter3811 in the direction Y causes the first catheter 3811 to move the firstgripping member 3810 in the direction X. Similarly, the second catheter3821 is configured to be pushed in the direction M while the line 3830is payed out of the first catheter 3811 or tension in the line 3830 isreduced. The second catheter 3821 is configured to be pulled in thedirection M while the line 3830 is pulled into the second catheter 3821or tension in the line 3830 is increased. Movement of the secondcatheter 3821 in the direction M causes the second catheter 3821 to movethe second gripping member 3820 in the direction H. In an alternativeembodiment, the control mechanism 3800 described above with reference toFIG. 189 can include a first flexible wire with a loop (e.g., theflexible wire 3714 with the loop 3716 shown in FIG. 188) and a secondflexible wire with a loop (e.g., the flexible wire 3724 with the loop3726 shown in FIG. 188), and the single line 3830 extends through theloop 3716, 3726 of each of the wires 3830.

Referring to FIG. 190, another exemplary embodiment of an actuation orcontrol mechanism 3900 includes a single line 3930, such as a suture orwire, that is removably attached to first and second clasps or grippingmembers 3910, 3920 and removably fixed between a positioning shaft 3904and a device shaft 3906 of an implantable device. The shafts 3904, 3906are similar to the hollow positioning and device shafts 3510, 3520,described in more detail above. The single line 3930 is connected at aconnection 3908 between the shafts 3904, 3906, such that the single line3930 can separately control the gripping members 3910, 3920. That is,movement of a first portion 3832 of the line 3830 in a direction Y willadjust a width W between the first gripping member 3910 and a firstpaddle 3914, but will not adjust a width H between the second grippingmember 3920 and a second paddle 3924. Similarly, movement of a secondportion 3934 of the line 3930 in a direction M will adjust a width Hbetween the second gripping member 3920 and a second paddle 3924, butwill not adjust the width W between the first gripping member 3910 andthe first paddle 3914. After the valve repair device is in a closedposition and secured to the native valve tissue, the positioning shaft3904 is detached from the device shaft 3906. Decoupling the shafts 3904,3906 releases the line 3930 from the connection 3908. The line 3930 canthen be retracted into the catheter 3902 to release the gripping members3910, 3920 by pulling one end of the line 3930 into the catheter 3902.Pulling one end of the line 3930 into the catheter 3902 pulls the otherend of the line 3930 through the gripping members 3910, 3920 and theninto the catheter 3902. Any of the lines described herein can beretracted in this manner.

Referring now to FIGS. 208A, 208B, 209A, and 209B, an exemplaryimplantable prosthetic device 4100, such as the devices described in thepresent application, is shown anchored to native leaflets 20, 22. Thedevice 4100 includes a coaption or spacer element 4102 and anchors 4104.The anchors 4104 attach the device 4100 to the leaflets 20, 22. As canbe seen in FIG. 208B, first and second gaps 26A, 26B remain between theclosed leaflets 20, 22 after the device 4100 is deployed. The coaptionelement 4102 includes first and second auxiliary, inflatable coaption orspacer elements 4106, 4108 that are shown in a deflated condition inFIGS. 208A and 208B.

Referring now to FIGS. 209A, 209B, the device 4100 is shown with theauxiliary coaption elements 4106, 4108 in an inflated condition. Thefirst and second auxiliary coaption elements 4106, 4108 can be inflatedto fill the first and second gaps 26A, 26B. Filling the gaps 26A, 26Ballows the leaflets 20, 22 to more fully seal around the device 4100.The auxiliary coaption elements 4106, 4108 are independently inflatableso that the first auxiliary coaption element 4106 can be inflated to adifferent size than the second auxiliary coaption element 4108 to filldifferent size gaps 26A, 26B.

Referring now to FIGS. 210A and 210B, an exemplary expandable coaptionor spacer element 4200 for use with a prosthetic implantable device ofthe present disclosure is shown. Referring now to FIG. 210A, theexpandable coaption element 4200 is shown in a compressed condition. Theexpandable coaption element 4200 is formed from a coiled wire 4202 thatis retained in the compressed condition by a retaining element 4204.Once the coaption element 4200 is in a desired location, an actuationsuture 4206 is used to pull the retaining element 4204 in an actuationdirection 4208. Removing the retaining element 4204 allows the coaptionelement 4200 to expand in an expansion direction 4210 to a larger,expanded size. The coaption element 4200 can be used as the auxiliarycoaption element 4016, 4018 in the embodiment of FIGS. 208A, 208B, 208C,and 208D.

Referring now to FIGS. 211A and 211B, an exemplary implantableprosthetic device 4300, such as the devices described in the presentapplication, is shown. The device 4300 extends from a proximal end 4301to a distal end 4303. Like the device 4100 described above, the device4300 includes a coaption or spacer element 4302 that has first andsecond auxiliary, inflatable coaption or spacer elements 4306, 4308 thatare shown in a deflated condition in FIG. 211A. Each auxiliary coaptionelement 4306, 4308 extends from a proximal end 4306A, 4308A to a distalend 4306B, 4308B. Referring now to FIG. 211B, the device 4300 is shownwith the auxiliary coaption elements 4306, 4308 in an inflatedcondition. When inflated, the proximal ends 4306A, 4308A and distal end4306B, 4308B have different sizes such that the auxiliary coaptionelements 4306, 4308 increase in size from the proximal 4306A, 4308A todistal ends 4306B, 4308B. In certain embodiments, the proximal ends arelarger than the distal ends. The varying width of the auxiliary coaptionelements 4306, 4308 improves coaption between leaflets (not shown) andthe device 4300 where the gaps between leaflets change in size from theproximal to distal ends 4301, 4303 of the device 4300.

Referring now to FIGS. 212A, 212B, 213A, 213B, 214, 215A, 215B, 216A,216B, 217A, 217B, and 218 an exemplary implantable prosthetic device4400, such as the devices described in the present application, isshown. Referring now to FIGS. 212A, 212B, 213A, 213B, and 214, thedevice 4400 includes a coaption or spacer element 4402, anchors 4404,and an attachment portion 4406. The attachment portion 4406 is athreaded rod that extends from the coaption element 4402 to receive anauxiliary coaption or spacer element 4410. The auxiliary coaptionelement 4410 has an inverted L-shape with an attachment opening 4412 anda spacer body 4414. The attachment opening 4412 receives the attachmentportion 4406 to attach the auxiliary coaption element 4410 to the device4400. The spacer body 4414 extends along one side of the coaptionelement 4402 to fill a gap (e.g., gaps 26A, 26B shown in FIG. 208B)between the leaflets. The auxiliary coaption element 4410 may have anysuitable shape and may vary in width and size like the inflatablespacers 4106, 4108, 4306, and 4308 described above.

Referring now to FIG. 214, the auxiliary coaption element 4410 is shownbeing assembled to the device 4400. The auxiliary coaption element 4410can be attached to the attachment portion 4406 of the device 4400 afterthe device 4400 has been implanted between the native leaflets (notshown) and anchored in place via the anchors 4404. As can be seen inFIGS. 215A and 215B, the auxiliary coaption element 4410 is secured tothe attachment portion 4406 with a nut 4408 after being attached to thedevice 4400. In certain embodiments, the attachment opening 4412 in theauxiliary coaption element 4410 is a slot to allow for lateraladjustment of the position of the auxiliary coaption element 4410without fully removing the auxiliary coaption element 4410 from thedevice 4400. That is, the nut 4408 may be loosened to allow the positionof the auxiliary coaption element 4410 to be adjusted after assembly tothe device 4400.

Referring now to FIGS. 216A, 216B, 217A, 217B, the device 4400 andauxiliary coaption element or spacer 4410 are shown with different meansof attaching the auxiliary coaption element 4410 to the device 4400 thanthe threaded rod and nut 4408 described above. The device 4400 shown inFIGS. 216A and 216B includes a circular magnet 4407 surrounding theattachment portion 4406. The auxiliary coaption element 4410 shown inFIGS. 217A and 217B includes a similarly shaped magnet 4413 surroundingthe attachment opening 4412 (which is shown as a hole, rather than aslot). When the auxiliary coaption element 4410 is assembled to thedevice 4400 opposite poles two magnets 4407, 4413 face each other andare attracted to each other and retain the auxiliary coaption element4410 on the device 4400 by way of magnetic attractive forces. In someembodiments, a plurality of magnets are provided on the device 4400and/or the auxiliary coaption element 4410.

Referring now to FIG. 218, a double-sided auxiliary coaption element4420 for attachment to the device 4400 is shown. The auxiliary coaptionelement 4420 has an inverted U-shape with an attachment opening 4422disposed between two coaption portions 4424. Like the auxiliary coaptionelement 4410 described above, the attachment opening 4422 receives theattachment portion 4406 to attach the auxiliary coaption element 4420 tothe device 4400. The coaption portions 4424 extend along both sides ofthe coaption element 4402 to fill gaps (e.g., gaps 26A, 26B shown inFIG. 208B) between the leaflets. The auxiliary coaption element 4420 mayhave any suitable shape and may vary in width and size like theinflatable spacers 4106, 4108, 4306, and 4308 described above.

Referring now to FIGS. 219A, 219B, an exemplary implantable prostheticdevice 4500, such as the devices described in the present application,is shown. The device 4500 includes a coaption or spacer element 4502 andattachment portions 4504 arranged on opposite sides of the coaptionelement 4502. The attachment portions 4504 are configured to receiveauxiliary coaption or spacer elements of varying shapes and sizes (FIGS.220A-220E). In the illustrated embodiment, the attachment portions 4504are shown as hoops that receive posts or pins 4512 of the auxiliarycoaption elements (FIGS. 220A-220E). Like the spacers 4410 shown above,the auxiliary coaption elements 4510A, 4510B, 4520A, 4520B, 4530A,4530B, 4540A, 4540B, 4550A, 4550B shown in FIGS. 220A-220E extend alongone or both sides of the coaption element 4502 to fill a gap (e.g., gaps26A, 26B shown in FIG. 208B) between the leaflets. To accommodate gapsof different sizes and shapes, the variety of auxiliary coaptionelements 4510A, 4510B, 4520A, 4520B, 4530A, 4530B, 4540A, 4540B, 4550A,4550B are provided with semi-circle, rounded triangular, or othersuitable shapes in a range of sizes. Different size and shape auxiliarycoaption elements 4510A, 4510B, 4520A, 4520B, 4530A, 4530B, 4540A,4540B, 4550A, 4550B can be attached to the coaption element 4502 toaccommodate gaps that are different shapes and sizes on opposite sidesof the coaption element 4502.

Referring now to FIGS. 221-223, an exemplary implantable prostheticdevice 4600 is shown. Referring now to FIG. 221, the device 4600 isshown cut from a flat sheet of material 4602, such as Nitinol, into alattice-like shape formed from a plurality of struts. The coaptionportion 4604 of the device 4600 includes auxiliary coaption portions4606 that expand outwards from the coaption element 4602 when the device4600 is formed into a three-dimensional shape. The auxiliary coaptionportions 4606 can be longer struts that are curved before the prostheticdevice is expanded. Referring now to FIG. 223, when the device isexpanded, the longer curved struts expand to form the auxiliary coaptionportions 4606. The expanded auxiliary coaption portions 4605 fill orpartially fill gaps 26 between the native leaflets 20, 22 when thedevice 4600 is implanted between the native leaflets 20, 22. In someembodiments, the coaption portion 4604 of the device is covered with acover (not shown) can be a cloth material such as polyethylene cloth ofa fine mesh. The cloth cover can provide a blood seal on the surface ofthe spacer, and/or promote rapid tissue ingrowth.

Referring now to FIGS. 224-225, an exemplary implantable prostheticdevice 4700 is shown. Referring now to FIG. 224, the device 4700 isshown cut from a flat sheet of material 4702, such as Nitinol. Thedevice 4700 includes coaption portions 4704, inner paddle portions 4706,outer paddle portions 4708, and a middle portion 4710. Referring now toFIG. 225, the device 4700 is shown folded into a three-dimensionalshape. The material 4702 is folded at the middle portion 4710 so thatthe various portions of each side of the material 4702 align. When thecoaption portions 4704 are aligned, a matrix of cut-outs in the material4702 form the coaption portion 4704 into a three-dimensional shapesimilar to the shape of the coaption elements described above.

While various inventive aspects, concepts and features of thedisclosures may be described and illustrated herein as embodied incombination in the exemplary embodiments, these various aspects,concepts, and features may be used in many alternative embodiments,either individually or in various combinations and sub-combinationsthereof. Unless expressly excluded herein all such combinations andsub-combinations are intended to be within the scope of the presentapplication. Still further, while various alternative embodiments as tothe various aspects, concepts, and features of the disclosures—such asalternative materials, structures, configurations, methods, devices, andcomponents, alternatives as to form, fit, and function, and so on—may bedescribed herein, such descriptions are not intended to be a complete orexhaustive list of available alternative embodiments, whether presentlyknown or later developed. Those skilled in the art may readily adopt oneor more of the inventive aspects, concepts, or features into additionalembodiments and uses within the scope of the present application even ifsuch embodiments are not expressly disclosed herein.

Additionally, even though some features, concepts, or aspects of thedisclosures may be described herein as being a preferred arrangement ormethod, such description is not intended to suggest that such feature isrequired or necessary unless expressly so stated. Still further,exemplary or representative values and ranges may be included to assistin understanding the present application, however, such values andranges are not to be construed in a limiting sense and are intended tobe critical values or ranges only if so expressly stated.

Moreover, while various aspects, features and concepts may be expresslyidentified herein as being inventive or forming part of a disclosure,such identification is not intended to be exclusive, but rather theremay be inventive aspects, concepts, and features that are fullydescribed herein without being expressly identified as such or as partof a specific disclosure, the disclosures instead being set forth in theappended claims. Descriptions of exemplary methods or processes are notlimited to inclusion of all steps as being required in all cases, nor isthe order that the steps are presented to be construed as required ornecessary unless expressly so stated. The words used in the claims havetheir full ordinary meanings and are not limited in any way by thedescription of the embodiments in the specification.

What is claimed is:
 1. A valve repair device for repairing a nativevalve of a patient, the valve repair device comprising: a strip ofmaterial; a coaption element formed from the strip of material; a pairof extension members extending from attachment portions; a pair ofpaddles formed from the strip of material and connected to the coaptionelement, wherein the paddles are movable between an open position and aclosed position, are disposed over the extension member, and areconfigured to attach to the native valve of the patient; and a capattached to the paddles, wherein movement of the cap toward the coaptionelement causes the pair of paddles to move to the closed position, andmovement of the cap away from the coaption element causes the pair ofpaddles to move to the open position, the cap comprising: a retentionbody having a locking aperture for receiving the attachment portions ofthe extension members; a retaining nut configured to insert into thelocking aperture; and a retaining bolt for securing the retaining nutwithin the locking aperture.
 2. The valve repair device of claim 1,further comprising: a collar attached to the coaption element; and ashaft extending through the collar to attach to the cap such that thecap can be moved by the shaft away from the collar; wherein movement ofthe cap toward the collar causes the pair of paddles to move to theclosed position, and movement of the cap away from the collar causes thepair of paddles to move to the open position.
 3. The valve repair deviceof claim 1, wherein the shaft is attached to the retaining nut of thecap.
 4. The valve repair device of claim 1, wherein the locking apertureextends through the retention body.
 5. The valve repair device of claim1, wherein the locking aperture is rectangular.
 6. The valve repairdevice of claim 1, wherein the locking aperture includes opposinglocking channels for receiving the attachment portions of the extensionmembers.
 7. The valve repair device of claim 6, wherein the opposinglocking channels have a rectangular shape.
 8. The valve repair device ofclaim 7, wherein the extension members have a rectangular cross-section.9. The valve repair device of claim 6, wherein each locking channelreceives two attachment portions of extension members.
 10. The valverepair device of claim 1, wherein the attachment portions of theextension members include hook portions for engaging the lockingaperture.
 11. The valve repair device of claim 10, wherein the hookportions engage opposing locking channels of the locking aperture. 12.The valve repair device of claim 1, wherein the attachment portions ofthe extension members include notches for engaging the locking aperture.13. The valve repair device of claim 12, wherein the notches engageopposing locking channels of the locking aperture.
 14. The valve repairdevice of claim 1, wherein the retaining bolt has a threaded portionextending from a flange.
 15. The valve repair device of claim 14,wherein the flange has a rounded shape.
 16. The valve repair device ofclaim 14, wherein the flange includes at least one recess for receivinga tool.
 17. The valve repair device of claim 1, wherein each extensionmember comprises a hoop.
 18. The valve repair device of claim 17,wherein the hoop extends between two attachment portions.
 19. The valverepair device of claim 18, wherein the two attachment portions arebiased to spread apart from each other.
 20. The valve repair device ofclaim 1, wherein the extension members are formed from a shape-memoryalloy.
 21. The valve repair device of claim 1, wherein the extensionmembers are formed from Nitinol.
 22. The valve repair device of claim 1,wherein: the locking aperture includes opposing locking channels forreceiving the attachment portions of the extension members eachextension member comprises a hoop extending between two attachmentportions; the extension members are formed from a shape-memory alloy;and the attachment portions are shape-set in a spaced apart relationshipthat is wider than a distance between the two locking channels.
 23. Thevalve repair device of claim 1, wherein the strip of material isattached to the cap such that the strip of material is prohibited frommoving relative to the cap.
 24. The valve repair device of claim 1,wherein the strip of material includes an opening for receiving theretaining bolt.
 25. The valve repair device of claim 1, wherein theretention body includes a channel for receiving the strip of material.26. The valve repair device of claim 25, wherein the channel is enclosedby a flange of the retaining bolt.
 27. The valve repair device of claim25, wherein the channel is narrower than a distance between the lockingchannels.
 28. The valve repair device of claim 25, wherein the channelis narrower than a width of the locking aperture.
 29. The valve repairdevice of claim 1, wherein the strip of material comprises metal strandsthat are woven together.
 30. The valve repair device of claim 1, whereinthe strip of material comprises an electrospun material.
 31. The valverepair device of claim 1, wherein the strip of material compriseselectrospun metal fibers.
 32. The valve repair device of claim 1,wherein the coaption element is configured to close a gap in the nativevalve of the patient when the valve repair device is attached to thenative valve.
 33. A method of manufacturing a valve repair device forrepairing a native valve of a patient, the method comprising: folding astrip of material to form a coaption element and a pair of paddlesconnected to the coaption element, wherein the paddles are movablebetween an open position and a closed position and are configured toattach to the native valve of the patient; attaching the portion of thestrip of material forming the paddles to a cap, wherein movement of thecap toward the coaption element causes the pair of paddles to move tothe closed position, and movement of the cap away from the coaptionelement causes the pair of paddles to move to the open position, the capcomprising: a retention body having a locking aperture for receiving theattachment portions of the extension members; a retaining nut configuredto insert into the locking aperture; and a retaining bolt for securingthe retaining nut within the locking aperture; attaching a pair ofextension members to the retention body of the cap via attachmentportions of the extension members such that the paddles are disposedover the extension members; and assembling the retaining bolt andretaining nut to secure the cap to the strip of material.
 34. The methodof claim 33, further comprising: a collar attached to the coaptionelement; and a shaft extending through the collar to attach to the capsuch that the cap can be moved by the shaft away from the collar.wherein movement of the cap toward the collar causes the pair of paddlesto move to the closed position, and movement of the cap away from thecollar causes the pair of paddles to move to the open position.
 35. Themethod of claim 33, wherein attaching the pair of extension members tothe cap further comprises: inserting the attachment portions of theextension members into the locking aperture of the retention body; andinserting the retaining nut into the locking aperture of the retentionbody after inserting the extension members.
 36. The method of claim 33,wherein the shaft is attached to the retaining nut of the cap.
 37. Themethod of claim 33, wherein the locking aperture extends through theretention body.
 38. The method of claim 33, wherein the locking apertureis rectangular.
 39. The method of claim 33, wherein the locking apertureincludes opposing locking channels for receiving the attachment portionsof the extension members.
 40. The method of claim 39, wherein theopposing locking channels have a rectangular shape.
 41. The method ofclaim 40, wherein the extension members have a rectangularcross-section.
 42. The method of claim 39, wherein each locking channelreceives two attachment portions of extension members.
 43. The method ofclaim 33, wherein the attachment portions of the extension membersinclude hook portions for engaging the locking aperture.
 44. The methodof claim 43, wherein the hook portions engage opposing locking channelsof the locking aperture.
 45. The method of claim 33, wherein theattachment portions of the extension members include notches forengaging the locking aperture.
 46. The method of claim 45, wherein thenotches engage opposing locking channels of the locking aperture. 47.The method of claim 33, wherein the retaining bolt has a threadedportion extending from a flange.
 48. The method of claim 47, wherein theflange has a rounded shape.
 49. The method of claim 47, wherein theflange includes at least one recess for receiving a tool.
 50. The methodof claim 33, wherein each extension member comprises a hoop.
 51. Themethod of claim 50, wherein the hoop extends between two attachmentportions.
 52. The method of claim 51, wherein the two attachmentportions are biased to spread apart from each other.
 53. The method ofclaim 33, wherein the extension members are formed from a shape-memoryalloy.
 54. The method of claim 33, wherein the extension members areformed from Nitinol.
 55. The method of claim 33, wherein: the lockingaperture includes opposing locking channels for receiving the attachmentportions of the extension members; each extension member comprises ahoop extending between two attachment portions; the extension membersare formed from a shape-memory alloy; and the attachment portions areshape-set in a spaced apart relationship that is wider than a distancebetween the two locking channels.
 56. The method of claim 33, whereinthe strip of material is attached to the cap such that the strip ofmaterial is prohibited from moving relative to the cap.
 57. The methodof claim 33, wherein the strip of material includes an opening forreceiving the retaining bolt.
 58. The method of claim 33, wherein theretention body includes a channel for receiving the strip of material.59. The method of claim 58, wherein the channel is enclosed by a flangeof the retaining bolt.
 60. The method of claim 58, wherein the channelis narrower than a distance between the locking channels.
 61. The methodof claim 58, wherein the channel is narrower than a width of the lockingaperture.
 62. The method of claim 33, wherein the strip of materialcomprises metal strands that are woven together.
 63. The method of claim33, wherein the strip of material comprises an electrospun material. 64.The method of claim 33, wherein the strip of material compriseselectrospun metal fibers.
 65. The method of claim 33, wherein thecoaption element is configured to close a gap in the native valve of thepatient when the valve repair device is attached to the native valve.